Actively Recruiting

Age: 35Years - 70Years
All Genders
Healthy Volunteers
NCT06806397

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

Led by Skolkovo Institute of Science and Technology · Updated on 2025-02-04

40

Participants Needed

2

Research Sites

39 weeks

Total Duration

On this page

Sponsors

S

Skolkovo Institute of Science and Technology

Lead Sponsor

F

Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent.
  • For stroke patients: first acute cerebrovascular accident and in early or late rehabilitation period.
  • Upper limb paresis severity from 0 to 3 points on a 6-point neurological scale.
  • Visual acuity of at least 0.2 on the Sivtsev scale.
  • Ability and willingness to follow the study protocol.
  • Strong motivation for rehabilitation.
  • For healthy volunteers: no somatic or psychiatric diseases and willingness to comply with study requirements.
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment (less than 10 points on Montreal Cognitive Assessment).
  • Hamilton depression score above 18.
  • Rankin scale score above 4.
  • Neurological disorders causing muscle weakness or stiffness (e.g., cerebral palsy, Parkinson's).
  • Late-stage arthritis or joint motion limitations.
  • Upper limb amputation.
  • Mental illness, epilepsy, or other conditions affecting safety or study results.
  • Alcohol or drug abuse in the past 12 months.
  • Recent use of experimental drugs or devices within 30 days.
  • Inability to follow study procedures.
  • Severe visual impairment below 0.2 Sivtsev.
  • Recent heart attack or unstable angina within one month.
  • Repeated stroke.
  • Severe unilateral spatial neglect.
  • Uncontrolled hypertension.
  • Ataxia.
  • Presence of metal or electrical implants.
  • Pregnancy.
  • Malignant tumors.
  • History of head injury, stroke, mental disorders, or drug addiction (for healthy volunteers).

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

Completed

2

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

Actively Recruiting

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Research Team

D

Daria Petrova, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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