Annex G4. NIHSS scale (National Institutes of Health Stroke Scale) - National Institutes of Health Stroke Scale

Sign Number of points

1. Eye opening:

2. Motor reaction 12 :

^ 3. Verbal response 13

The sum of points in three sections and its correspondence to the level of consciousness

Motor Deficits Rating Scale (Zacharia)

Range of motion	Number of points
Absence of all movements	0
Contraction of a part of the muscles without a motor effect in the corresponding joint	1
Muscle contraction with a motor effect in the joint without the possibility of elevating the limb	2
Muscle contraction with limb elevation without the possibility of overcoming the additional load applied by the examiner's hand	3
Active movement of the limb with the ability to overcome the additional load applied by the examiner's hand	4
Normal strength. The examiner cannot overcome the resistance of the examinee when extending the arm	5

Glasgow Immediate Outcome Scale

1 point	Death in the first 24 hours.
2 points	Death in more than 24 hours.
3 points	Persistent vegetative state: vital functions are stable; neuromuscular and communicative functions are deeply disturbed; the phases of sleep and wakefulness are preserved; the patient may be in the conditions of special care of the intensive care unit.
4 points	Neuromuscular failure: the mental status is within the normal range, however, a deep motor deficit (tetraplegia) and bulbar disorders force the patient to remain in a specialized intensive care unit.
5 points	Severe disability: A severe physical, cognitive and/or emotional disability that precludes self-care. The patient can sit, eat independently. Immobile and in need of nursing care.
6 points	Moderate lack of independence: mental status within the normal range. Some daily functions can be performed by itself. Communication problems. Can move with assistance or with special devices. Needs outpatient care.
7 points	Slight lack of independence: mental status within the normal range. The patient serves himself, can walk on his own or with outside support. Needs special employment.
8 points	Good recovery: the patient returns to the previous stereotype of life, although not everything is still working out. Complete autonomy, although residual neurological impairment may occur. Walks independently without assistance.
9 points	Complete recovery: complete recovery to the premorbid level without residual effects in the somatic and neurological status.

National Institutes of Health Stroke Scale

Developed by the American National Institutes of Health

(National Institutes of Health Stroke Scale - NIH Stroke Scale)

T. Brott et al, 1989, J. Biller et al, 1990.

It is used to objectify the state of a patient with ischemic stroke at admission, in the dynamics of the process and the outcome of a stroke by the 21st day of hospitalization.

The scale contains 15 points that characterize the main functions that are most often impaired due to cerebral stroke. Functions are evaluated in points. The scale is notable for its obvious simplicity, filling it takes no more than 5-10 minutes, disciplines the doctor in terms of the need for a comprehensive study of the neurological status, and allows you to record the dynamics of the patient's condition in the acute period of the disease. The internal consistency and retest reliability of the scale has been confirmed by a number of studies (Goldstein J.C. et al 1989). The absence of changes in the neurological status is provided as 0 points, the death of the patient - 31 points.

sign	score	Description
Consciousness: the level of wakefulness	0	clear Stunning (inhibited, drowsy, but responds even to a slight stimulus - a command, a question) Stupor (requires repeated, strong, or painful stimulation in order to move or become temporarily available to contact) Coma (not available for speech contact, responds to stimuli only with reflex motor or autonomic reactions)
Consciousness: answers to questions. Ask the patient to name the month of the year and their age.	0	Correct answers to both questions Correct answer to one question Wrong answers to both questions
Consciousness: following instructions They ask the patient to open and close his eyes, clench his fingers into a fist and unclench them.	0	Executes both commands correctly Executes one command correctly Both commands execute incorrectly
Eyeball movements	0	Norm Partial gaze paralysis (but no fixed gaze deviation) Fixed deviation of the eyeballs
Fields of view (explored using finger movements that the researcher performs simultaneously on both sides)	0	No violations Partial hemianopia Complete hemianopia Bilateral hemianopsia
Paralysis of the facial muscles	0	Not Moderately pronounced Full
Movements in the hand on the side of the paresis The hand is asked to be held for 10 seconds in a 90 ° flexion position at the shoulder joint if the patient is sitting; and at 45° flexion if the patient is lying down	0	The hand doesn't go down No active movements
Movements in the opposite hand (stem stroke)	0	The hand doesn't go down The patient first holds his hand in a given position, then the hand begins to fall The hand begins to fall immediately, but the patient still somewhat holds it against gravity. The hand immediately falls, the patient cannot overcome gravity at all No active movements
Movements in the leg on the side of the paresis The patient lying on his back is asked to hold the leg raised (bent in hip joint) at an angle of 30°	0	No active movements
Movements in the opposite leg (stem stroke)	0	The leg does not go down for 5 seconds The patient first holds the leg in a given position, then the leg begins to lower The leg begins to fall immediately, but the patient still somewhat holds it against gravity. The leg immediately falls, the patient cannot overcome gravity at all No active movements
Ataxia in the limbs Finger-nose and heel-knee tests (ataxia is scored in the case when it is disproportionate to the degree of paresis; with complete paralysis it is coded with the letter “H”) 14	0	Not Available either at the top or at lower limb Present in both upper and lower extremities
Sensitivity Examined with a pin, only violations by hemitype are taken into account	0	Norm Slight decrease Significantly reduced
Syndrome of "denial"	0	Not Partial Full
dysarthria	0	Normal articulation Mild or moderate dysarthria Slurred speech
Aphasia Assessed by the patient's speech responses during his examination	0	Not Mild or moderate aphasia Severe aphasia Mutism

Classification of the severity of the condition in subarachnoid hemorrhage according to Hunt-Hess

(Henry J.M. Barnett, Stroke: Pathophysiology, Diagnosis and Management, 1986)

This scale is additionally used to assess the severity of the patient's condition with intracranial hemorrhage or cerebellar infarction (0-V degree); patients whose condition corresponds to grade 0-III have no contraindications on this scale for hospitalization in the neurosurgical department.

Degree	Characteristic
0	Unruptured aneurysm
I	Asymptomatic or minimal headache and mild neck stiffness
IA	Absence of meningeal or cerebral symptoms, but persistent neurological deficit
II	moderate or severe headache, stiff neck; no neurological deficit other than cranial nerve palsy
III	Stunning-stupor, confusion (disorientation in time and space) or mild local deficit
IV	Sopor, moderate or deep hemiparesis, possible early decerebrate rigidity, and autonomic disturbances
V	Deep coma, decerebrate rigidity and signs of agony

Barthel ADL index of daily life activity

(F.Mahoney, D.Barthel, 1965; C.Granger et al, 1979; D.Wade, 1992)

Instruction

The index should reflect the real actions of the patient, and not the intended ones (not how the patient could perform certain functions).
The main purpose of testing is to establish the degree of independence from any help, physical or verbal, no matter how insignificant this help is and no matter what the reasons are.
The need for supervision means that the patient does not belong to the category of those who do not need help (the patient is not independent).
The level of functioning should be determined in the best possible way for a particular situation among those possible: most often by questioning the patient, his friends/relatives or caregivers, but direct observation and common sense are also important. Direct testing is not required.
Usually, the patient's functioning is assessed in the period preceding 24-48 hours, but sometimes a longer assessment period is justified.
Medium categories mean that the patient performs more than 50% of the effort required to perform a particular function.
The category "independent" allows the use of aids.

^ Defecation control

0 - incontinence (or needs to use an enema, which is put by the caregiver);

5 - random incidents (not more than once a week) or assistance is required when using an enema, suppositories;

10 - complete control of defecation, if necessary, can use an enema or suppositories, does not need help;

^ Urination control

0 - incontinence or a catheter is used, which the patient cannot manage independently;

5 - random incidents (maximum once per 24 hours);

10 - complete control of urination (including those cases of catheterization Bladder when the patient is self-managed with the catheter).

^ Personal hygiene (brushing teeth, handling dentures, combing, shaving, washing face)

0 - needs help with personal hygiene procedures;

5 - independent when washing the face, combing, brushing teeth, shaving (tools for this are provided)

^ Going to the toilet (moving around the toilet, undressing, cleaning skin dressing, leaving the toilet)

5 - needs some help, but some of the actions, incl. hygiene procedures, can perform independently;

10 - does not need help (when moving, taking off and putting on clothes, performing hygiene procedures);

^ Eating

0 - completely dependent on the help of others (feeding with assistance is necessary);

5 - partially needs help, for example, when cutting food, spreading butter on bread, etc., while eating independently;

10 - does not need help (able to eat any normal food, not only soft; independently uses all the necessary cutlery; food is prepared and served by others, but not cut);

^ Transfer (from bed to chair and back)

0 - movement is impossible, unable to sit (balance), two people are required to get out of bed;

5 - when getting out of bed, significant physical assistance is required (one strong / trained person or two ordinary persons), can sit up on his own in bed;

10 - when getting out of bed, little help is required (physical, one person), or supervision, verbal help is required;

15 - does not need help.

^ Mobility (movements within the home/room and outside the home; assistive devices may be used)

0 - unable to move;

5 - can move around with the help of a wheelchair, incl. go around corners and use doors;

10 - can walk with the help of one person (physical support or supervision and moral support);

15 - does not need help (but can use assistive devices, such as a cane).

Dressing

0 - completely dependent on the help of others;

5 - partially needs help (for example, when fastening buttons, buttons, etc.), but performs more than half of the actions independently, can put on some types of clothing completely independently, spending a reasonable amount of time on this;

10 - does not need help, incl. when fastening buttons, buttons, tying shoelaces, etc., can choose and wear any clothing.

^ Climbing stairs

0 - unable to climb stairs, even with support;

5 - needs supervision or physical support;

10 - does not need help (can use aids).

^ Taking a bath

0 - takes a bath (enters and leaves it, washes) without assistance and supervision or washes in the shower without requiring supervision and assistance;

5 - needs help.

When assessed by NIHSS scale it is necessary to strictly follow the sections of the scale, registering points in each of the subsections in turn. You can not go back and change the previously set ratings. Follow the instructions for each of the subsections. The score should reflect what the patient is actually doing, not what the investigator thinks the patient can do. Record the answers and assessments of the test subject during the study, work quickly. Unless indicated in the instructions for the appropriate subsection, the patient should not be coached and/or made to perform better on the command.

wakefulness level

If a full examination is not possible (for example, due to an endotracheal tube, a language barrier, or damage to the orotracheal area), the overall level of responses and reactions is assessed.
Grade 3 is given only in cases where the patient is in a coma and does not respond to pain stimuli or his reactions are reflex in nature (extension of the limbs).

Clear mind, responsive

Stunning and/or somnolence; responses and instructions can be achieved with minimal stimulation.

Deep stupor or stupor, reacts only to strong and painful stimuli, but the movements are not stereotyped.

Atony, areflexia and unresponsiveness or responses to stimuli consist of reflex non-purposeful movements and/or autonomic reactions.

Level of wakefulness: answers to questions

The patient is asked to name the current month and their age. Answers must be exact, you can not count the answer, which is close to the correct one. If the patient does not perceive the question (aphasia, a significant decrease in the level of wakefulness), a score of 2 is given. If the patient cannot speak due to mechanical obstructions (endotracheal tube, damage to maxillofacial area), severe dysarthria, or other problems not related to aphasia, a score of 1 is given. It is important that only the first response is scored and that the investigator does not assist the patient in any way.

Correct answers to both questions.

Correct answer to one question.

Didn't answer both questions.

Wakefulness level: executing commands

The patient is asked to open and then close the eyes, clench and unclench the fist of the non-paralyzed hand. If there are obstacles (for example, it is impossible to use the hand), replace this command with another command that provides a one-step action. If an explicit attempt is made, but the action is not completed due to weakness, the result is read. If the patient does not respond to the utterance of the command, he should demonstrate what is required of him, and then evaluate the result (repeated both, one or none). Only the first attempt is scored.

Run both commands.

Run one command.

Didn't follow any of the commands.

Eyeball movements

Norm.

Partial paresis of the gaze; the movements of one or both eyes are disturbed, but there is no tonic deviation of the eyeballs and complete paralysis of the gaze.

Tonic deviation of the eyeballs or complete paralysis of the gaze, which persists when checking oculocephalic reflexes.

Fields of view

Visual fields (upper and lower quadrants) are examined by confrontation, by counting the number of fingers or frightening sudden movements from the periphery to the center of the eye. It is possible to give appropriate prompts to patients, but if they look in the direction of moving fingers, this can be regarded as the norm. If one eye does not see or is missing, the second is examined. A score of 1 is given only if there is a clear asymmetry (including quadrantanopia). If the patient is blind (for any reason), a 3 is given. Simultaneous stimulation on both sides is also examined here, and if there is hemiignorance, a 1 is put and the result is used in the "Hemiignorance (neglect)" section.

Fields of vision are not broken.

Partial hemianopia.

Complete hemianopia.

Blindness (including cortical).

Dysfunction of the facial nerve

Normal symmetrical movements of facial muscles.

Slight paresis of mimic muscles (smoothed nasolabial fold, asymmetrical smile).

Moderate prosoparesis (complete or pronounced paresis of the lower group of facial muscles).

Paralysis of one or both halves of the face (lack of movement in the upper and lower parts of the face).

Strength of the muscles of the left arm

There are no movements in the hand.

impossible to explore.

Right hand muscle strength

The extended arm is set at an angle of 90° (if the patient is sitting) or 45° (if the patient is lying) to the body with palms down and the patient is asked to hold it in this position for 10 s. First evaluate the non-paralyzed hand, then the other. With aphasia, you can help to take the starting position and use pantomime, but not painful stimuli. If it is impossible to examine the strength (the limb is missing, ankylosis in the shoulder joint, fracture), an appropriate mark is made.

The arm does not go down for 10 s.

The hand begins to descend before the 10 s elapses, but does not touch the bed or other surface.

The hand is held for some time, but within 10 seconds it touches a horizontal surface.

The hand immediately falls, but there are movements in it.

There are no movements in the hand.

impossible to explore.

Strength of the muscles of the left leg

There is no movement in the leg.

impossible to explore.

Strength of the muscles of the right leg

Always examined in the supine position. The patient is asked to raise the leg at an angle of 30° to the horizontal surface and hold in this position for 5 seconds. With aphasia, you can help to take the starting position and use pantomime, but not painful stimuli. The non-paralyzed leg is evaluated first, then the other. If it is impossible to examine the strength (the limb is missing, ankylosis in the shoulder joint, fracture), an appropriate mark is made.

The leg is not lowered for 5 s.

The leg begins to descend before 5 s elapses, but does not touch the bed.

The leg is held for some time, but within 5 seconds it touches the bed.

The leg immediately falls, but there are movements in it.

There is no movement in the leg.

impossible to explore.

Ataxia in the limbs

This section provides for the identification of signs of damage to the cerebellum on the one hand. The study is carried out with open eyes. If there is a limitation of the visual fields, the study is carried out in the area where there are no violations. Finger-nose-finger and knee-heel tests are performed on both sides. Points are awarded only when the severity of ataxia exceeds the severity of paresis. If the patient is not available for contact or is paralyzed, there is no ataxia. If the patient cannot see, a finger-nose test is performed. If it is impossible to examine the strength (the limb is missing, ankylosis in the shoulder joint, fracture), an appropriate mark is made.

There is no ataxia.

Ataxia in one limb.

Ataxia in two limbs.

impossible to explore.

Sensitivity

It is examined with the help of pricks with a pin (toothpick) and touches. In case of impaired consciousness or aphasia, grimaces, withdrawal of a limb are evaluated. Only hypoesthesia caused by a stroke (by hemitype) is evaluated, therefore, for verification, it is necessary to compare the reaction to injections in different parts of the body (forearms and shoulders, hips, torso, face). A score of 2 is given only in cases where a gross decrease in sensation in one half of the body is not in doubt, so patients with aphasia or impaired consciousness at the level of stupor will receive a 0 or 1. With bilateral hemihypesthesia caused by a stem stroke, a 2 is given. Patients in a coma automatically get 2.

Norm.

Mild or moderate hemihypesthesia; on the affected side, the patient feels the injections as less sharp or as touches.

Severe hemihypesthesia or hemianesthesia; the patient does not feel any injections or touches.

Speech

Information regarding the understanding of addressed speech has already been obtained in the course of the study of the previous sections. To study speech production, the patient is asked to describe the events in the picture, name objects and read a passage of text (see Appendix). If the study of speech is hindered by vision problems, ask the patient to name the objects placed in his hand, repeat the phrase and tell about some event from his life. If an endotracheal tube is placed, the patient should be asked to complete the tasks in writing. Patients in a coma automatically receive 3. In case of impaired consciousness, the assessment is determined by the researcher, but 3 is set only for mutism and complete disregard for simple commands.

Norm.

mild or moderate aphasia; speech is distorted or comprehension is disturbed, but the patient can express his thought and understand the researcher.

severe aphasia; only fragmentary communication is possible, understanding the patient's speech is very difficult, according to the patient, the researcher cannot understand what is shown in the pictures.

Mutism, total aphasia; the patient does not utter any sounds and does not understand the addressed speech at all.

dysarthria

You do not need to tell the patient what exactly you are going to evaluate. With normal articulation, the patient speaks clearly, he does not have difficulty pronouncing complex combinations of sounds, tongue twisters. In severe aphasia, the pronunciation of individual sounds and fragments of words is assessed, with mutism, 2 is put. If it is impossible to examine the force (intubation, facial trauma), an appropriate mark is made.

Norm.

mild or moderate dysarthria; some sounds are "blurred", the understanding of words causes some difficulties.

Rough dysarthria; the words are so distorted that they are very difficult to understand (the reason is not aphasia), or anartria / mutism is noted.

research impossible

Hemiignorance (neglekt)

Sensory hemiignorance is understood as a violation of perception on one half of the body (usually the left) when stimuli are applied simultaneously on both sides in the absence of hemihypesthesia. Visual hemiignorance is understood as a violation of the perception of objects in the left half of the visual field in the absence of left-sided hemianopia. As a rule, the data from the previous sections is sufficient. If it is not possible to examine visual hemiignorance due to visual impairment, and the perception of pain stimuli is not impaired, the score is 0. Anosognosia indicates hemiignorance. The assessment in this section is given only in the presence of hemishoring, so the conclusion "it is impossible to investigate" does not apply to it.

Norm.

Signs of hemiignorance of one type of stimuli (visual, sensory, auditory) were revealed.

Signs of hemiignorance of more than one type of stimuli were revealed; does not recognize his hand or perceives only half of the space.

In contact with

Every neurologist is familiar with the National Institutes of Health Stroke Scale (NIHSS). After all, it is her data that is used to decide on the advisability of thrombolytic therapy, evaluate its effectiveness, and also to determine the prognosis of the disease. The principle is this: the more points on the NIHSS scale, the more severe the condition.

In the case of a neurological deficit of more than 3 points on the NIHSS scale, this is regarded as an indication for thrombolytic therapy. If the patient's condition corresponds to more than 25 points on this scale, this is a relative contraindication to thrombolysis. There is evidence that with a score of less than 10 points, the probability of a favorable outcome after 1 year = 60-70%, and with a score of more than 20 points = 4-16%.

Evgeny Chernyshkov contributed to the popular scale appearing in smartphones medical workers. So, back in 2012, the NIHSS application for Android devices appeared, which works safely on both smartphones and tablets.

Compatible with Android devices only.

Language: Russian, English.

National Institutes of Health Stroke Scale (NIHSS)

1. Level of consciousness:

0 - conscious, actively reacting;
1 - doubt, but wake up with minimal irritation, follow commands, answer questions;
2 - stupor, requires repeated stimulation to maintain activity or lethargy, and requires strong and painful stimulation to produce non-stereotypical movements;
3 - coma, reacts only with reflex actions or completely does not respond to stimuli

2. Level of consciousness - questions:

Ask the patient what month it is and his age. Write down the first answer.

If aphasia and stupor - score 2.

If endotracheal tube, trauma, severe dysarthria, language barrier score 1.

0 - the correct answer to both questions;
1 - the correct answer to one question;
2 - none of the questions were answered correctly

3. Level of consciousness - execution of commands:

The patient is asked to open and close their eyes, then to squeeze and unclench their non-paralyzed hand. Only the first attempt counts:

0 - both commands are executed correctly;
1 — one command was executed correctly;
2 - no command executed correctly

4. Movement of the eyeballs:

Only horizontal eye movements are taken into account:

0 - norm;
1 - partial paralysis of the gaze;
2 - tonic abduction of the eyes or complete paralysis of the gaze, not overcome by the induction of oculocephalic reflexes

5. Examination of visual fields:

0 - norm;
1 - partial hemianopsia;
2- complete hemianopsia

6. Paresis of the facial muscles:

0 - norm;
1 - minimal paralysis (asymmetry);
2 - partial paralysis - complete or almost complete paralysis of the lower muscle group;
3 - complete paralysis (lack of movement in the upper and lower muscle groups)

7. Movements in the upper limbs:

The arms are raised for 10 seconds at an angle of 45 degrees if the patient is lying down, and 90 degrees if the patient is sitting. If the patient does not understand, then the doctor must place the hands in position himself. Scores are recorded separately for the right and left limbs:

On right:

4 - no active movements;

Left:

0 - no lowering for 10 seconds;
1 - lowers after a short hold (before 10 seconds);
2 - limbs cannot rise or maintain an elevated position, but produce some resistance to gravity;
3 - limbs fall without resistance to gravity;
4 - no active movements;
9 - impossible to check (limb mutated, artificial joint)

8. Movements in the lower limbs:

If the patient is lying, raise the paretic leg for 5 seconds at an angle of 30º.

Scores are recorded separately for the right and left limbs.

On right:

3 - limbs fall without resistance to gravity;
4 - no active movements;
9 - impossible to check (limb amputated, artificial joint)

Left:

0 - no lowering for 5 seconds;
1 - lowers after a short hold (before 5 seconds);
2 - the limbs cannot rise or maintain an elevated position, but offer some resistance to gravity;
3 - limbs fall without resistance to gravity;
4 - no active movements;
9 - impossible to check (limb amputated, artificial joint)

9. Ataxia of limbs:

Finger-nose and heel-to-knee tests are carried out on both sides. Ataxia is counted if it is not due to weakness:

0 - absent;
1 - in one limb;
2 - in two limbs

10. Sensitivity:

Only hemitetype disorder is taken into account:

0 - norm;
1 - mild or moderate violations;
2 - significant or complete violation of sensitivity.

11. Aphasia:

Ask the patient to describe the picture, name the object, read the sentence:

0 - no aphasia;
1 - mild aphasia;
2 - severe aphasia;
3 - complete aphasia

12. Dysarthria:

0 - normal articulation;
1 - soft or medium. May not pronounce some words;
2 - severe dysarthria
9 - intubated or other physical barrier

13. Agnosia (ignorance):

0 - no agnosia;
1 - ignoring to bilateral sequential stimulation of one sensory modality;
2 - severe hemiagnosia or hemiagnosia in more than one modality.

Total score:

Interview with Nathan Bornstein

Interview with Nathan Bornstein

Nathan M. Bornstein (IL), MD

Neurological Department, Medical Center. Sorasky, Tel Aviv

Nathan M. Bornstein is Professor and Head of the Department of Neurology at the Medical Center. Elias Sorasky, Faculty of Medicine. Sackler, Tel Aviv University, Israel.

Dr. Bornstein's research interests include: lateralized epileptiform discharges (PLEDs) that developed after a stroke and are associated with metabolic disorders, non-valvular atrial fibrillation, menopause and ischemic stroke, the role of hormone replacement therapy, antiplatelet agents in the treatment of strokes, infection as a triggering factor ischemic stroke, transcranial Doppler sonography, dynamics and treatment of asymptomatic carotid stenosis and clinical significance of hemorrhages in carotid plaques.

Dr. Bornstein is a lead researcher for the Tel Aviv Stroke Registry and the Mediterranean Stroke Society, and a member of the European Stroke Registry. Author and co-author of more than 90 scientific articles on cerebrovascular diseases published in such journals as Stroke, Neurology, Adverse Neurology, Cardiology, Acta Diabetologiсa, Cerebrovascular Diseases, Lancet, Archives of Neurology, Headache, The Journal of Neurological Sciences, The European Journal of Neurology.

— Professor Bornstein, you recently visited Seoul and took part in the work of the International Stroke Congress. What are the most significant scientific and clinical studies you would highlight?

— This year was not marked by such cutting-edge research as ECASS III in 2008 conducted in Vienna. However, the congress presented the results of several important studies, namely the SENTIS study on the use of the NeuroFlo catheter to enhance cerebral circulation in acute ischemic stroke, and CASTA regarding the use of Cerebrolysin in the treatment of acute ischemic stroke. Also noteworthy were the brilliantly delivered lectures by Dr. Cohen and Dr. Dirnagl on impressive preclinical results. scientific research in stroke models.

- Professor Bornstein, you personally participated in the CASTA study. How would you comment on the main results of the study?

- Yes, that's right. I served on the Steering Committee and therefore have some responsibility for the design of this study. More than 1060 patients were included, of which more than 900 completed the study. The final results of the study regarding primary performance indicators were neutral. However, we think that this was probably due to the fact that a large proportion of the study patients experienced mild strokes, with a median NIHSS stroke score of 9, as too many mild cases were included in the study. , then the “ceiling effect” could be strongly manifested.

— Professor Geiss, an ardent supporter of evidence-based medicine, presented the results of the CASTA study from an optimistic and positive perspective. What are these conclusions about?

— I think that at the time of presentation of the data, the possible existence of a “ceiling effect” was correctly pointed out, which may explain the neutral results of the study. However, Cerebrolysin showed significant beneficial effects in a subgroup of patients with baseline NIHSS > 12 or even higher (NIHSS > 17). These effects should be taken into account by clinicians as this is the first case among clinical research strokes, when the neuroprotective agent demonstrates such a pronounced clinical efficacy.

Could you tell us a little more about these beneficial effects?

— In a subgroup of 246 people enrolled in the CASTA study with NIHSS scores > 12 in the study drug group, there was an improvement of approximately 5 points on the NIHSS after 90 days, compared with the control group, where the decrease was less than 2 points . This difference of 3 points indicates the development of a very pronounced clinical improvement in the treatment of patients with Cerebrolysin. It is also important to note that positive effects were observed already on the 10th day of treatment - the point in time when clinicians can decide to intensify neurorehabilitation if the patient's biological state is stable. For many patients, this decline means that if they start rehabilitation early, instead of a long-term course of the disease, their condition will improve continuously.

- Were the results obtained in patients with strokes in the right or left hemispheres different?

- As far as I know, no. This indicates that improvement occurs in any case, regardless of the side of the damage. However, we must wait for the final report of the results of the study, which will appear sometime at the end of December, in order to more accurately answer the question of which subgroups of patients benefited most from Cerebrolysin therapy.

- Please explain if any positive effect can be expected in patients with mild stroke, since CASTA does not give a clear answer to this question.

- A positive effect can also be determined in patients suffering from mild forms of stroke and having, accordingly, low values on the NIHSS scale. However, many more patients must be included in the study for this to happen. Imagine, for example, two patients with mild stroke, one in the placebo group and one in the Cerebrolysin group, with an NIHSS score of 8. As you are well aware, mild stroke usually improves within 90 days to the point where the neurological impairment is very small and the patients' cognitive/motor function can be restored. As a result, it is difficult to identify a significant therapeutic effect in this group.

Previous studies have shown that Cerebrolysin helps such patients recover faster, which improves the quality of life of patients and their caregivers. We can also assume that patients who recover faster do not develop post-stroke depression, which often occurs with a long course of disorders.

“Another important aspect of stroke research is data on the safety of treatment. What were they like in the CASTA study?

“One of the most important benefits of Cerebrolysin has always been the safe profile of its use, and this was again confirmed in the CASTA study, for the first time in more than 1000 patients. In particular, there was a trend towards a decrease in mortality in the Cerebrolysin group by 1.3%. I think that this figure will be even higher in the subgroup of patients with more severe lesions in the final report. But for now, all of this is just speculation.

- Do you believe that, in the end, convincing data can be obtained on the possibility of a significant neuroprotective effect in ischemic stroke?

- Yes, I believe. However, we must understand that for many years, neuroscientists around the world have had high hopes that neuroprotective effects could become a proven therapy in acute stroke in addition to r-tPA. But, the results of several studies fell short of these expectations.

What kind of research do you mean?

– Recent studies include the SAINT study on NXY-059 and the EAST study on the acceptor free radicals under the name "Edaravon". In both cases, we received negative results. We can also recall the great review by James Grotta in 2004, which looked at drugs tested as neuroprotective agents, with negative results in almost all cases.

Do you believe in the future of Cerebrolysin?

“From my point of view, more research needs to be done on the use of Cerebrolysin in acute ischemic stroke. However, the pronounced positive trends in the subgroups of the CASTA study should impress both the pharmaceutical company and the medical community. As is known, for only a small number of drugs, certainty in relation to evidence has been achieved in one step. However, the first step is always the hardest, and the first step taken in this Cerebrolysin study was very impressive for both the pharmaceutical company and us stroke specialists.

— Cerebrolysin is a biological drug with a complex multimodal action. Don't you think that this complexity is part of the answer to why Cerebrolysin is a good candidate for hard evidence?

You raised a very interesting question. In parallel with clinical research, we must also study the mechanisms of action of Cerebrolysin in acute stroke. Preclinical data indicate that Cerebrolysin is a multimodal drug that is useful for both neuroprotection in acute stroke and long-term neurorehabilitation. In addition, due to its ability to influence the ischemic cascade at various levels (pleiotropic effect), it is the most suitable candidate for neuroprotection in the acute period of stroke.

If you remember Stephen Davis' lecture at the International Stroke Congress in Seoul, he noted that there is already proof of concept related to Cerebrolysin, the only thing missing is randomized controlled trials (RCTs). We already know that the mechanism of action of Cerebrolysin is pleiotropic and multimodal. In this regard, it is appropriate to recall that back in 2006, Marc Fisher expressed the opinion that the best candidates for identifying efficacy in large RCTs are agents with multimodal effects, including neurotrophic factors.

Cerebrolysin may even be a better candidate than neurotrophic factors alone due to its more pronounced multimodal properties. This is due to the fact that it mimics the influence of neurotrophic factors, and the active peptides contained in the preparation are small enough to pass through the blood-brain barrier, which enhances the effect.

- Well, let's finish this interview, look into the future. What do you think will happen next in Cerebrolysin research?

- Within a few recent weeks I discussed with my colleagues the CASTA study and its results. The signal I received is clear enough that everyone hopes that the sponsor will soon initiate a new study, the design of which will be adjusted to focus only on patients with moderate to severe strokes, which may require higher doses. drug or increase the duration of treatment.

We have important lessons to learn from the CASTA study. And if the subgroup analysis proves to be justified, then the next study is likely to find positive significant results, which will be an excellent achievement in the treatment of strokes.

— Professor Bornstein, we would like to thank you for sharing with us information about this important congress held in Seoul, and in particular about the CASTA study.

Thank you for your questions. Was happy to help.

How to understand how badly a person suffered from a stroke? One hand does not move - is it strong or not very? And if the ability to live in our reality is lost?

There is no need to guess: there are special scales that allow you to assess how badly the brain is affected. Using them in the initial stages, doctors get a fairly accurate prognosis of a stroke. Further, according to these scales, it is assessed whether there are any changes in the patient's condition.

NIHHS scale

This is a scale that is applied from the first minutes of the disease. They work with her immediately after the diagnosis is established, by the number of points they decide already in the first hour whether thrombolysis can be performed or it will be dangerous. The NIHHS scale from the US National Institutes of Health is the most common method for assessing the severity of a person's condition after a stroke.

The test takes 10-15 minutes. It is important to evaluate all items in order, without first instructing the patient. The point is awarded for the person's actual reactions, not possible ones. As a result, the points are summed up.

Question	Points
1. Clarity of mind	0 - Doesn't sleep, answers 2-3 questions clearly and ambiguously
	1 - Doubtful: answers correctly, with pauses, but - after you have awakened him with mild stimulation
	2 - Sopor. Opens eyes only in response to hard tapping or pain (for example, squeezing urine in the ear). Doesn't answer questions
	3 - Deep stubble. In response to a painful stimulus, a series of protective movements or increased breathing occurs.
2. Level of consciousness - speech You need to ask: “What month is it now?” And how old are you?"	0 - Answers correctly, the first time, to both questions
	1 - Answers correctly only 1 question, or the tube of the breathing apparatus prevents him from answering, or speech is simply blurry, incomprehensible
	2 - Not responding at all
3. Follow simple instructions You need to ask to open and close your eyes, move your fist on the hand that can move. If a person does not understand what they want from him, it is necessary to demonstrate the action. Only the first effort is evaluated	0 - Completed everything exactly
	1 - Executed one instruction or made an explicit attempt to do so
	2 - Did nothing
4. How the eyes move in the horizontal direction To check, eye contact is established with a person, and then you need to step aside, following how he looks at you. People with a clear mind can be asked to follow the pen, which you will hold horizontally	0 - Eyes move normally
	1 – eyeballs not moving enough. This point is also awarded without a test if strabismus has developed as a result of a stroke.
	2- No eye movement
5. Fields of view	0 - Fields of view are OK
	1 - Partial loss of one of the halves of the field of view - closest to the nose or located on the other side
	2 - Complete loss of half of the field of view
	3 - Blindness, even if it was before the stroke
6. How the facial nerve works To check, you need to ask in words or pantomime that you need to bare your teeth, puff out your cheeks, close your eyes	0 - When following these instructions on the face, everything contracts symmetrically
	1 - The crease between the nose and the lip on one side is slightly smoothed, when the cheeks are puffed out, one corner of the mouth slightly drops and the air comes out, the smile is a little asymmetrical
	2 - The smile is clearly asymmetrical, it is impossible to hold the air with puffed out cheeks
	3 - One or both eyes do not close, the cheek (cheeks) cannot be puffed out, when the teeth are bared, the corner (corners) of the mouth drops sharply
7. Arm muscle strength The arm must be unbent and placed at a right angle in the sitting or at 45 ° - in the recumbent, the palm is turned down. Ask to hold your hand for 10 seconds while counting the time First, the non-paralyzed arm is examined. If there is no arm or there is a disease of the shoulder joint, the test is not performed	0 - Hands held for 10 seconds
	1 - The hand falls before the right time, but by the 10th second does not touch the bed (support)
	2 - The hand is held slightly, but until the 10th second it touches the surface
	3 - He can raise his hand himself, but he cannot hold it
	4 - Independent movement is not possible
8. Strength of leg muscles To do this, the person himself needs to raise his leg and hold it at an angle of 30 ° for 5 seconds. Research rules - as in paragraph No. 7	0 - Leg is held for 5 s
	1 - Before the 5th second, the leg descends, but does not touch the bed
	2 - Touches the bed until the 5th second
	3 - The leg is not held, but the patient raised it himself
	4 - The leg itself does not move
9. Definition of cerebellar lesion This is a finger-nose test, which is performed with open eyes. Carried out only on the side where there is no loss of field of view If the person is unconscious or paralyzed, the test is scored as 0 points. If there are no limbs, there is a fracture, or the joints do not work, the test is not performed	0 - Touches the fingers of both hands to the nose
	1 - Does not hit the nose with only one hand
	2 - Misses the nose with both hands
10.Sensitivity It is explored by pricking the arms and legs with a toothpick, starting from the foot/hand, moving up. Injections are made alternately on one and the other limb If the consciousness is unclear, then the grimace that occurs in response to pain is evaluated.	0 - No sensory disturbances
	1 - On the affected side, tingling sensations are felt as less acute
	2 - No pricks or touches are felt on one or both sides. If a person is in a coma, he is automatically awarded 2 points.
11. Speech To do this, they take a picture and ask them to describe the events depicted on it. You can ask to read the text. If the patient is conscious, but the apparatus breathes for him, then they are asked to describe the events in writing	0 - No deviations
	1 - Minor violations
	2 - Can't say anything coherently
	3 - Says nothing or is in a coma
12. Disorders of articulation Assessed by the intelligibility of speech when repeating text or words: football player Oil Clumsiness Come down from heaven to earth Near the dining table in the dining room They heard him speak on the radio last night	0 - Speech is intelligible
	1 - Speech is clear, but only some sounds are slurred
	2 - There is speech, but it is almost impossible to understand it, and the patient himself hears it
	Failed - If the person is on a ventilator or has a severely injured face
13. Complex perception of sensory signals on one half of the body It is carried out only if sensitivity is normal on both sides	0 - Nothing damaged
	1 - On the one hand, one type of signal is not perceived: sounds, smells, vision of objects
	2 - On the one hand, 2 or more signals of various kinds are not perceived. Doesn't recognize his hand, understands only half of the space

Interpretation

If the assessment is carried out in the acute period, when the issue of thrombolysis (drug dissolution of the thrombus that caused the stroke) is being decided, then the assessment is as follows:

5-24 points - the procedure can be performed;
0-4 points - thrombolysis will not be able to affect the prognosis and development of disability.

If you need to estimate the chance of a full recovery in a year, then look like this:

less than 10 points - a chance of 60-70%;
more than 20 points - a chance of 4-16%.

Scandinavian scale

It assesses the severity of ischemic stroke in its acute period (that is, from the moment of occurrence to 7 days) and then in dynamics:

Scandinavian scale

Interpretation

If the difference between the original and second score is 10 points or more, it is considered a significant improvement. Moderate positive dynamics - if 3-10 points. Slight improvement - a difference of 1-2 points.

Simultaneously with the Scandinavian scale, laboratory results and functional research methods are evaluated.

Rankin scale

It is used to understand the long-term perspective: what kind of care the patient will need.

Rankin scale

Interpretation

Grade 0: No household help required.
1 degree: need help 1 time per month.
Grade 2: Without help, he can do no more than 1 week.
Grade 3: Need help several times a week. Plus, the person needs psychological help.
Grade 4: help is needed daily, but you can leave a person alone - for a short period of time.
Grade 5: care is needed constantly.

Rivermead scale

It measures a person's ability to move after a stroke. It does not mean movement with the help of improvised means or a wheelchair.

The calculation is as follows: for each answer "Yes" - 1 point. The scores are then added up.

Rivermead scale

Interpretation

0-1 points: Need a 24-hour caregiver or continued stay in the hospital;
2-3 points: rehabilitation measures are needed in a hospital at a polyclinic;
4-7 points: recovery is carried out either without hospitalization, or with a short stay in a hospital with continued rehabilitation in a polyclinic;
8 or more points: polyclinic rehabilitation is sufficient.

You can independently evaluate the condition of your relative who suffered from a stroke using these scales. This will help you draw your own conclusions about his condition.

It is used to assess the neurological status, localization of a stroke (in the carotid or vertebrobasilar basin), differential diagnosis and treatment results. It is based on a number of parameters that reflect the levels of impairment of the main disorders due to acute cerebrovascular disease. The NIHSS score is essential for planning thrombolytic therapy and monitoring its effectiveness. Thus, an indication for thrombolytic therapy is the presence of a neurological deficit (more than 3 points on the NIHSS scale), suggesting the development of disability. Severe neurological deficit (more than 25 points on this scale) is a relative contraindication to thrombolysis and does not significantly affect the outcome of the disease. Also, the results of the assessment of the state on the NIHSS scale make it possible to roughly determine the prognosis of the disease. So, with a score of less than 10 points, the probability of a favorable outcome after 1 year is 60 - 70%, and with a score of more than 20 points, 4 - 16%.

Patient Evaluation Criteria

Number of points on the NIHSS scale

The study of the level of consciousness - the level of wakefulness

(if the study is not possible due to intubation, language barrier - the level of reactions is assessed)

0 - conscious, actively responding.

1 - doubt, but can be awakened with minimal irritation, executes commands, answers questions.

2 - sopor, repeated stimulation is required to maintain activity or is inhibited and strong and painful stimulation is required to produce non-stereotypical movements.

3 - coma, reacts only with reflex actions or does not respond to stimuli.

Wakefulness test - answers to questions

The patient is asked to answer the questions: "What month is it now?", "How old are you?"

(if the study is not possible due to intubation, etc. - put 1 point)

0 - Correct answers to both questions.

1 - The correct answer to one question.

2 - Didn't answer both questions.

Examination of the level of wakefulness - execution of commands

The patient is asked to perform two actions - close and open the eyelids, squeeze a non-paralyzed hand, or move the foot

0 - both commands are executed correctly.

1 - one command executed correctly.

2 - none of the commands were executed correctly.

Eyeball movements

The patient is asked to follow the horizontal movement of the neurological malleus.

0 is the norm.

1 - partial paralysis of the gaze.

2 - tonic abduction of the eyes or complete gaze paralysis, not overcome by the induction of oculocephalic reflexes.

Study of visual fields

We ask the patient to say how many fingers he sees, while the patient must follow the movement of the fingers

0 is the norm.

1 - partial hemianopia.

2 - complete hemianopsia.

Determination of the functional state of the facial nerve

we ask the patient to show his teeth, make movements with his eyebrows, close his eyes

0 is the norm.

1 - minimal paralysis (asymmetry).

2 - partial paralysis - complete or almost complete paralysis of the lower muscle group.

3 - complete paralysis (lack of movement in the upper and lower muscle groups).

Assessment of the motor function of the upper limbs

The patient is asked to raise and lower their arms 45 degrees in the supine position or 90 degrees in the sitting position. If the patient does not understand the commands, the doctor independently places his hand in the desired position. This test measures muscle strength. Points are fixed for each hand separately

0 - limbs are held for 10 seconds.

1 - limbs are held for less than 10 seconds.

2 - limbs do not rise or do not maintain a given position, but produce some resistance to gravity.

4 - no active movements.

5 - impossible to check

(limb amputated, artificial joint)

Assessment of motor function of the lower extremities

Raise the parathecal leg in the prone position by 30 degrees for a duration of 5 seconds.

Points are fixed for each leg separately

0 - legs are held for 5 seconds.

1 - limbs are held for less than 5 seconds.

2 - Limbs do not rise or do not maintain an elevated position, but offer some resistance to gravity.

3 - limbs fall without resistance to gravity.

4 - no active movements.

5 - impossible to check (limb amputated, artificial joint).

Assessment of motor coordination

This test detects ataxia by evaluating cerebellar function.

A finger-nose test and a heel-knee test are performed. Assessment of violation of coordination is made from two sides.

0 - No ataxia.

1 - Ataxia in one

limbs.

2 - Ataxia in two limbs.

UN - it is impossible to investigate (the reason is indicated)

Sensitivity test

examining the patient with a needle, roller to test sensitivity

0 is the norm.

1 - mild or moderate sensory disturbances.

2 - significant or complete impairment of sensitivity

Identification of a speech disorder

0 - Norm.

1 - Mild or moderate

dysarthria; some sounds are blurred, understanding of words

causes difficulties.

2 - Severe dysarthria; the patient's speech is difficult, or mutism is determined.

UN - it is impossible to investigate (specify the reason).

Identification of perceptual disturbances - hemiignoring or negligence

0 - Norm.

1 - Signs of hemiignorance of one type of stimulus (visual, sensory, auditory) are revealed.

2 - Signs of hemiignorance of more than one type of stimuli were revealed; does not recognize his hand or perceives only half of the space.