Neurophysiological Markers for Prediction of Rehabilitation Outcomes After Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Upper Limb Motor Impairment. Basic parameters: 40 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurophysiological Markers for Developing an Integrative Model of Rehabilitation Prognosis in Patients With Ischemic Stroke
Overview
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
- Device Intermittent Theta Burst Stimulation
Once a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1). - Device Sham Intermittent Theta Burst Stimulation
Once a day, 10 days of Sham Theta-Burst Stimulation using placebo coil
Primary outcome measures
- Change in Muscle Strength Assessed by the Medical Research Council Scale (MRC) [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Muscle Tone Assessed by the Modified Ashworth Scale (MAS) [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Upper Limb Motor Function (Fugl-Meyer Assessment - Upper Extremity) [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
Secondary outcome measures (4)
- Change in Modified Rankin Scale (mRS) score [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Action Research Arm Test (ARAT) score [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Nine-Hole Peg Test (NHPT) completion time [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
- Change in Frenchay Arm Test (FAT) score [Time frame: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports M — Moscow
Identifiers
NCT: NCT07520630 · NMIRP-IS-2026-01