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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
First-ever ischemic stroke confirmed by CT/MRI
5 days - 6 months post-stroke
Age 40-65
MoCA ≥20
Implanted electronic devices
Epilepsy
Severe cardiac arrhythmias
Intracranial aneurysm
Parallel
Intermittent Theta Burst Stimulation
DeviceOnce a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1).
Sham Intermittent Theta Burst Stimulation
DeviceOnce a day, 10 days of Sham Theta-Burst Stimulation using placebo coil
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.
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.
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.
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.
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.
Change in Action Research Arm Test (ARAT) score
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
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
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
