Study of Hemodynamic Markers of Upper Extremity Motor Dysfunction in Stroke Patients Using Functional Near Infrared Spectroscopy (fNIRS)

Recruiting now

Conditions studied: Stroke, Stroke with Hemiparesis, Stroke, Ischemic

In brief

The aim of the study was to explore potential pathways for recovery and adaptation of the motor cortex by examining cerebral blood flow characteristics and hemodynamic markers analyzed by functional near-infrared spectroscopy (fNIRS) in patients with hemiparesis after stroke. Participants in the study performed a simple stimulus-response task several times with one healthy and one paralyzed limb at different stages of basic rehabilitation. A group of healthy, age-matched volunteers participated in the same experiment to verify the stroke-related changes. The researchers recorded fNIRS signals, muscle activity using electromyography, and heart activity using electrocardiography.

Key facts

Study ID

NCT06806397

Run by

Skolkovo Institute of Science and Technology

People needed

40

Starts

2024-06-26

Expected to finish

2025-04-01

Last updated by the study team

2025-02-04

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• The presence of superficial injury of head (S00-S09 International Classification of Diseases 10 (ICD-10).
• The presence of mental, behavioural disorders (F00-F99 ICD-10).
• Drug addiction in the past or at the moment.
• The presence of diseases of the nervous system (G00-G99 ICD-10).
• . History of intracranial injury (S06 ICD-10) or stroke (I64 ICD-10).
• The presence of somatoform disorders (F45 ICD-10).
• Any conditions that, in the opinion of the Investigator, meet the exclusion criteria
• 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).
• Pregnancy
• The presence of malignant neoplasms (C00-C97 ICD-10).
• For stroke patients:
• Inclusion Criteria:
• Signed written informed consent.
• People after the first acute cerebrovascular accident (CVA), early or late rehabilitation period.
• The level of severity of paresis of the upper limb from 3 points to 0 (according to a 6-point neurological scale)
• The minimum visual acuity is not lower than 0.2 on the Sivtsev scale.
• The ability and willingness of the patient to comply with the requirements of this protocol.
• Expressed patient motivation for rehabilitation.
• Exclusion Criteria:
• Severe cognitive impairment (<10 points according to the Montreal Cognitive Assessment Scale).
• Hamilton score above 18 points.
• The score on the Rankin scale is above 4 points.
• 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).
• 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.
• The absence of a part of the upper limb due to amputation caused by various reasons.

Where it is running

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

Full record on ClinicalTrials.gov

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