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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].
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS | Experimental |
| |
| Sham-iTBS | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta Burst Stimulation | Device | Once a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Rankin Scale (mRS) score | Global disability assessed using the modified Rankin Scale (mRS). Scores range from 0 to 6, higher scores indicate greater disability. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Action Research Arm Test (ARAT) score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Event-Related Desynchronization (ERD) of Sensorimotor Rhythm | Event-related desynchronization (ERD) of sensorimotor rhythm in the 8-30 Hz frequency range measured using scalp electroencephalography during motor execution and motor imagery tasks. ERD is expressed as percentage decrease in band power relative to a pre-movement baseline, reflecting cortical activation. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
Experimental phase:
will include healthy volunteers without contradictions to TMS
Clinical phase:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul D. Egorov | Contact | +7-977-878-11-60 | egorovpd@vk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine | Moscow | Russia |
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| Sham Intermittent Theta Burst Stimulation | Device | Once a day, 10 days of Sham Theta-Burst Stimulation using placebo coil |
|
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. |
| Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Nine-Hole Peg Test (NHPT) completion time | 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. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Frenchay Arm Test (FAT) score | 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. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Event-Related Synchronization (ERS) of Sensorimotor Rhythm | Event-related synchronization (ERS) of sensorimotor rhythm in the 8-30 Hz frequency range measured using scalp electroencephalography during motor execution and motor imagery tasks. ERS is expressed as percentage increase in band power relative to a pre-movement baseline, reflecting post-movement cortical synchronization. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Movement-Related Cortical Potential (MRCP) Amplitude | Amplitude of movement-related cortical potential (MRCP) recorded using scalp electroencephalography during motor execution and motor imagery tasks. MRCP amplitude is measured in microvolts (µV) relative to a pre-movement baseline and reflects cortical activity associated with motor preparation. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Movement-Related Cortical Potential (MRCP) Latency | Latency of movement-related cortical potentials (MRCPs) recorded using scalp electroencephalography during motor execution and motor imagery tasks. MRCP latency is defined as the time interval in milliseconds (ms) between MRCP onset and movement onset. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Motor Evoked Potential (MEP) Amplitude | Peak-to-peak amplitude of motor evoked potentials (MEPs) recorded at rest from the target upper limb muscle using surface electromyography following single-pulse transcranial magnetic stimulation of the primary motor cortex. MEP amplitude is measured in millivolts (mV) and reflects corticospinal excitability. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Resting Motor Threshold (RMT) | Resting motor threshold (RMT) defined as the minimum stimulator intensity required to evoke motor evoked potentials (MEPs) in the target muscle in at least 50% of trials with the muscle at rest. The threshold is expressed as a percentage of maximal stimulator output (% MSO). | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| Change in Weighted Phase Lag Index (wPLI) in the Sensorimotor Network | Functional connectivity within the sensorimotor network assessed using the weighted phase lag index (wPLI), a phase-based connectivity measure derived from electroencephalography signals during motor execution and motor imagery tasks. wPLI values range from 0 to 1, with higher values indicating stronger phase synchronization between cortical regions. | Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham) |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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