Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients.

NCT06386627 | Completed

• 2 other identifiers: Skoltech-CNBR321-75-30024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. Investigators recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, investigators also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections.

Conditions

Stroke

Keywords

stroke; hemiparesis; motor cortex; restoration of motor functions; upper limbs

Outcome Measures

Primary Outcomes (1)

• Atypical shape of lateralized readiness potential

  Shape and scalp-distribution of the lateralized pre-motor cortical potentials in post-stroke participants demonstrated bilateral involvement of primary motor cortex, indicating role of healthy hemisphere in the control of impaired limb movements.

  15 days

Secondary Outcomes (1)

• Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres

  1 day

Study Arms (2)

Post-stroke persons

Diagnostic Test: Stimulus response task; Diagnostic Test: Transcranial magnetic stimulation

Healthy volunteers

Diagnostic Test: Stimulus response task

Interventions

Stimulus response task DIAGNOSTIC_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 volunteers; Post-stroke persons

Transcranial magnetic stimulation DIAGNOSTIC_TEST

Transcranial magnetic stimulation to assess the integrity of corticospinal connections

Post-stroke persons

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.

Sponsors & Collaborators

• Skolkovo Institute of Science and Technology: lead
• Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia: collaborator

Study Sites (1)

Skolkovo Institute of Science and Technology (Skoltech)

Moscow, Russia

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: July 1, 2023
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

RU (1)