Neurophysiological Markers for Prediction of Rehabilitation Outcomes After Ischemic Stroke

NCT07520630 | Not Yet Recruiting

• 1 other identifier: NMIRP-IS-2026-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled study is to develop and validate an integrated neurophysiological model for predicting rehabilitation potential in patients with ischemic stroke. The study focuses on identifying objective markers of brain activity associated with motor preparation and recovery. The project includes two stages. First, healthy volunteers will participate in experimental motor and mental tasks to establish reference patterns of brain activity using electroencephalography and transcranial magnetic stimulation. These data will be used to define stable neurophysiological markers of motor network function. In the second stage, patients in the acute and early recovery phases after ischemic stroke will be randomly assigned to receive either active intermittent theta-burst stimulation of the motor cortex or a sham procedure, in addition to standard rehabilitation. Brain activity and clinical motor function will be assessed before and after the intervention. The study aims to determine which neurophysiological measures are sensitive to neuromodulation and are associated with clinical improvement, in order to construct a predictive model of rehabilitation outcome. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Conditions

Ischemic Stroke; Upper Limb Motor Impairment

Outcome Measures

Primary Outcomes (4)

• Change in Muscle Strength Assessed by the Medical Research Council Scale (MRC)

  Muscle strength of the affected upper limb assessed using the Medical Research Council (MRC) scale, ranging from 0 (no muscle contraction) to 5 (normal muscle strength). Higher scores indicate better motor function.

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Muscle Tone Assessed by the Modified Ashworth Scale (MAS)

  Muscle tone of the affected upper limb assessed using the Modified Ashworth Scale (MAS), which ranges from 0 (no increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension). Higher scores indicate greater spasticity.

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity)

  Upper limb motor impairment assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). Scores range from 0 to 66, with higher scores indicating better upper limb motor function.

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)

  Global cognitive function assessed using the Montreal Cognitive Assessment (MoCA), a 30-point cognitive screening tool. Scores range from 0 to 30, with higher scores indicating better cognitive function.

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

Secondary Outcomes (4)

• Change in Modified Rankin Scale (mRS) score

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Action Research Arm Test (ARAT) score

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Nine-Hole Peg Test (NHPT) completion time

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Frenchay Arm Test (FAT) score

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

Other Outcomes (7)

• Change in Event-Related Desynchronization (ERD) of Sensorimotor Rhythm

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Event-Related Synchronization (ERS) of Sensorimotor Rhythm

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

• Change in Movement-Related Cortical Potential (MRCP) Amplitude

  Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)

Study Arms (2)

iTBS

EXPERIMENTAL

Device: Intermittent Theta Burst Stimulation

Sham-iTBS

SHAM COMPARATOR

Device: Sham Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

Once a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1).

iTBS

Sham Intermittent Theta Burst Stimulation DEVICE

Once a day, 10 days of Sham Theta-Burst Stimulation using placebo coil

Sham-iTBS

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever ischemic stroke confirmed by CT/MRI
• days - 6 months post-stroke
• Age 40-65
• MoCA ≥20
• HADS \<11 for anxiety and depression
• MRC 2-4 in upper limb
• Modified Ashworth Scale ≤3
• Signed informed consent

You may not qualify if:

• Implanted electronic devices
• Epilepsy
• Severe cardiac arrhythmias
• Intracranial aneurysm
• Decompensated somatic disease
• Pregnancy/lactation

Sponsors & Collaborators

• Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine: lead

Study Sites (1)

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Moscow, Russia

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Paul D. Egorov

CONTACT

+7-977-878-11-60; egorovpd@vk.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: April 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

RU (1)