NCT06806397

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

StrokeStroke with HemiparesisStroke, Ischemic

Keywords

strokehemiparesishemodynamicsfNIRSrestoration of motor functionNeurovascular coupling

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic changes after stroke

    In post-stroke subjects, an increase in blood flow and oxygenation was observed in sensorimotor cortical regions of both hemispheres during movement of the paretic limb. This observation may indicate that the healthy hemisphere contributes to the execution of movement.

    14 days

Study Arms (2)

Individuals after stroke

Diagnostic Test: Stimulus response task

Healthy volunteers

Diagnostic Test: Stimulus response task

Interventions

Stimulus response taskDIAGNOSTIC_TEST

Participants were tasked with performing a finger extension exercise that required pressing buttons in response to visual stimuli. In cases where physical movement was not possible, participants were instructed to imagine performing the task while focusing on their fingers.

Healthy volunteersIndividuals after stroke

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing rehabilitation at the Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia

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).
  • 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:
  • 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.
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

COMPLETED

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

StrokeIschemic StrokeParesis

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Daria Petrova, PhD

CONTACT

+7 915 420 5113d.petrova@skoltech.ru

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 4, 2025

Study Start

June 26, 2024

Primary Completion

January 20, 2025

Study Completion

April 1, 2025

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations

RU(2)