Ischemic StrokeNCT07520630
Neurophysiological Markers for Prediction of Rehabilitation Outcomes After Ischemic Stroke
A study testing Intermittent Theta Burst Stimulation in people with Ischemic Stroke and Upper Limb Motor Impairment, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Upper Limb Motor Impairment
- What is being tested?
- Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- May 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Implanted electronic devices
- Epilepsy
- Severe cardiac arrhythmias
- Intracranial aneurysm
- Decompensated somatic disease
- Pregnancy/lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Moscow
Paul D. Egorov, +7-977-878-11-60, egorovpd@vk.com
About this study
Official title: Neurophysiological Markers for Developing an Integrative Model of Rehabilitation Prognosis in Patients With Ischemic Stroke
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.
Read more
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].
Read the 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.
- Conditions
- Ischemic Stroke, Upper Limb Motor Impairment
- Being tested
- Intermittent Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
Once a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1).
Sham Intermittent Theta Burst StimulationDevice
Once a day, 10 days of Sham Theta-Burst Stimulation using placebo coil
| Study group | Role | What they receive |
|---|---|---|
| iTBS | Experimental | Not described Receives: Device: Intermittent Theta Burst Stimulation |
| Sham-iTBS | Sham comparator | Not described Receives: Device: Sham Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)
Secondary outcomes (4)
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.
Measured: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 2 (end of intervention, after 10 sessions of iTBS/Sham)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520630
- Sponsor's protocol ID
- NMIRP-IS-2026-01
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Markers for Developing an Integrative Model of Rehabilitation Prognosis in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07520630
- Acronym / sponsor ID
- NMIRP-IS-2026-01
- Conditions
- Ischemic Stroke, Upper Limb Motor Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports MedicineUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTBS | Experimental | Device: Intermittent Theta Burst Stimulation |
| Sham-iTBS | Sham comparator | Device: Sham Intermittent Theta Burst Stimulation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Implanted electronic devices
- Epilepsy
- Severe cardiac arrhythmias
- Intracranial aneurysm
- Decompensated somatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Theta Burst StimulationOnce a day, 10 days of Intermittent Theta-Burst Stimulation (iTBS) applied to ipsilesional primary motor cortex (M1). | Device | iTBS |
| Sham Intermittent Theta Burst StimulationOnce a day, 10 days of Sham Theta-Burst Stimulation using placebo coil | Device | Sham-iTBS |
Primary outcome
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)
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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation in people with Ischemic Stroke and Upper Limb Motor Impairment, run by Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul D. Egorov (+7-977-878-11-60, egorovpd@vk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.