Examining brain blood flow in stroke patients with motor dysfunction

Studying the Mechanisms of Visual-motor Transformation to Find Neurophysiological Markers of Altered Functions of Cortical Motor Circuits in Patients with Neurological Disorders and Developing Technologies for Their Rehabilitation.

This study is testing how blood flow in the brain relates to movement problems in stroke patients to see if it can help us understand their recovery better.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 35 Years to 70 Years
• Sex: All
• Sponsor: Skolkovo Institute of Science and Technology (Academic / other)
• Locations: 2 sites (Moscow and 1 other locations)
• Trial ID: NCT06806397 on ClinicalTrials.gov

What this trial studies

This study investigates the hemodynamic markers associated with upper extremity motor dysfunction in stroke patients using functional near-infrared spectroscopy (fNIRS). It involves 40 participants, including individuals with hemiparesis due to stroke and healthy controls, who perform a stimulus-response task to assess their reaction speed. The study records fNIRS signals, muscle activity through electromyography, and heart activity via electrocardiography to analyze cerebral blood flow characteristics and potential recovery pathways in the motor cortex.

Who should consider this trial

Good fit: Ideal candidates for this study are stroke patients with hemiparesis who are undergoing rehabilitation.

Not a fit: Patients with significant psychiatric disorders, other neurological diseases, or those with certain medical implants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of motor recovery mechanisms in stroke patients, potentially leading to improved rehabilitation strategies.

How similar studies have performed: While the use of fNIRS in stroke rehabilitation is gaining interest, this specific approach to examining hemodynamic markers in relation to motor dysfunction is relatively novel.

Eligibility criteria

For Healthy Volunteers:

Inclusion Criteria:

1\. Availability of signed written informed consent. 3. Absence of somatic and psychiatric diseases (more details in the exclusion criteria) 4. Ability and willingness to comply with the requirements of this protocol.

Exclusion Criteria:

1. The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
2. The presence of mental, behavioural disorders (F00-F99 ICD-10).
3. Drug addiction in the past or at the moment.
4. The presence of diseases of the nervous system (G00-G99 ICD-10).
5. . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
6. The presence of somatoform disorders (F45 ICD-10).
7. Any conditions that, in the opinion of the Investigator, meet the exclusion criteria
8. Presence of electrical and/or metallic implants or stimulants in the body (eg, implanted deep brain stimulation devices, pacemakers, hearing aids and cochlear implants, intracranial metal implants).
9. Pregnancy
10. The presence of malignant neoplasms (C00-C97 ICD-10).

For stroke patients:

Inclusion Criteria:

1. Signed written informed consent.
2. People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
3. The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
4. The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
5. The ability and willingness of the patient to comply with the requirements of this protocol.
6. Expressed patient motivation for rehabilitation.

Exclusion Criteria:

1. Severe cognitive impairment (\<10 points according to the Montreal Cognitive Assessment Scale).
2. Hamilton score above 18 points.
3. The score on the Rankin scale is above 4 points.
4. Associated neurological disorders that cause decreased muscle strength or increased muscle tone in the upper limbs (eg, cerebral palsy, brain damage from trauma) or stiffness (eg, Parkinson's disease, contracture).
5. Late stages of arthritis or clinically significant limitation of passive range of motion in any of the joints studied in the study due to other reasons.
6. The absence of a part of the upper limb due to amputation caused by various reasons.
7. Any medical condition, including mental illness or epilepsy, that may affect the interpretation of study results, study conduct, or patient safety.
8. Alcohol abuse, medical marijuana use, or recreational drug use in the 12 months prior to Visit 1.
9. Use of experimental drugs or medical devices within 30 days prior to Visit 1.
10. Lack of ability to follow study procedures, in the opinion of the investigator.
11. The severity of the patient's condition according to the neurological or somatic status, which does not allow full rehabilitation.
12. Severe visual disturbances, minimal visual acuity less than 0.2 Sivtsev visual acuity table.
13. Unstable angina and/or heart attack within the previous month
14. Repeated stroke.
15. Severe unilateral spatial neglect.
16. Uncontrolled arterial hypertension
17. Ataxia
18. All forms of epilepsy

Where this trial is running

Moscow and 1 other locations

• Skolkovo Institute of Science and Technology (Skoltech) — Moscow, Russia (Completed)
• Skolkovo Institute of Science and Technology (Skoltech) — Moscow, Russia (Recruiting)

Study contacts

• Study coordinator: Daria Petrova, PhD

Conditions Stroke; Stroke with Hemiparesis; Stroke, Ischemic; stroke; hemiparesis; hemodynamics; fNIRS; restoration of motor function