Ischemic Stroke, Upper Limb Motor Impairment
Conditions
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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
Detailed description
Stroke remains a leading cause of long-term disability worldwide. Motor recovery after ischemic stroke is highly variable, and currently available clinical scales provide limited ability to predict rehabilitation potential at the individual level. There is a need for objective, neurophysiologically grounded biomarkers that reflect motor network integrity, cortical excitability, and adaptive neuroplasticity. The present study aims to develop and validate an integrated neurophysiological model for predicting rehabilitation outcomes in patients with ischemic stroke. The model is based on a multimodal assessment combining electroencephalography (EEG), performed during standardized ecologically valid motor and mental paradigms, and diagnostic transcranial magnetic stimulation (TMS). The project consists of two interconnected stages. Stage 1 (Experimental Reference Phase in Healthy Volunteers): Healthy adult participants will perform standardized motor execution and motor imagery paradigms under EEG and surface electromyography monitoring. Cortical excitability will be assessed using diagnostic TMS. This phase is designed to identify stable neurophysiological patterns associated with motor preparation and execution, including movement-related cortical potentials, sensorimotor rhythm modulation, and measures of functional connectivity. These data will serve as reference patterns to define candidate biomarkers for subsequent clinical testing. Stage 2 (Randomized Controlled Clinical Phase): Patients in the acute and early recovery stages following first-ever ischemic stroke will be randomly assigned to receive either active intermittent theta-burst stimulation (iTBS) of the ipsilesional primary motor cortex or sham stimulation, in addition to standard rehabilitation therapy. The intervention course will consist of multiple stimulation sessions delivered over a two-week period. Neurophysiological assessments (EEG and diagnostic TMS) will be conducted before and after the intervention. Clinical motor and cognitive function will be evaluated using standardized scales at baseline and post-intervention time points. The randomized design allows evaluation of the sensitivity of candidate neurophysiological markers to neuromodulatory intervention and their association with clinical recovery dynamics. By integrating electrophysiological measures of cortical excitability, motor network synchronization, and interregional connectivity with clinical outcomes, the study seeks to identify a minimal set of objective markers capable of predicting rehabilitation response. The ultimate objective is to construct and statistically validate a predictive model of rehabilitation potential that may support individualized planning of post-stroke neurorehabilitation strategies.
Interventions
DEVICEIntermittent Theta Burst Stimulation
Once a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1).
Once a day, 10 days of Sham Theta-Burst Stimulation using placebo coil
Sponsors
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Experimental phase: will include healthy volunteers without contradictions to TMS Clinical phase: Inclusion Criteria: * First-ever ischemic stroke confirmed by CT/MRI * 5 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
Exclusion criteria
* Implanted electronic devices * Epilepsy * Severe cardiac arrhythmias * Intracranial aneurysm * Decompensated somatic disease * Pregnancy/lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle Strength Assessed by the Medical Research Council Scale (MRC) | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | 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. |
| Change in Muscle Tone Assessed by the Modified Ashworth Scale (MAS) | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | 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. |
| Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity) | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | 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. |
| Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Rankin Scale (mRS) score | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | Global disability assessed using the modified Rankin Scale (mRS). Scores range from 0 to 6, higher scores indicate greater disability. |
| Change in Action Research Arm Test (ARAT) score | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | Upper limb functional capacity assessed using the Action Research Arm Test (ARAT). Scores range from 0 to 57, with higher scores indicating better upper limb function. |
| Change in Nine-Hole Peg Test (NHPT) completion time | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | Manual dexterity assessed using the Nine-Hole Peg Test (NHPT), a timed test of fine hand dexterity. Completion time is recorded in seconds; lower times indicate better manual dexterity. |
| Change in Frenchay Arm Test (FAT) score | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) | Upper limb functional performance in daily activities assessed using the Frenchay Arm Test (FAT), a 5-item test of arm and hand function after stroke. Scores range from 0 to 5, with higher scores indicating better upper limb function. |
Countries
Russia
Contacts
CONTACTPaul D. Egorov
Outcome results
None listed