StrokeNCT07121582
Modulation of Brain Rhythms in Stroke
A study testing Motor Brain Stimulation and Visual Brain Stimulation in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this research study is to examine communication between brain and muscle in individuals with stroke and determine if applying non-invasive brain stimulation to different parts of the brain improves this communication and performance on a hand squeezing task. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Motor Brain Stimulation and Visual Brain Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Jan 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic (≥ 6 months) unilateral cortical/subcortical ischemic or hemorrhagic stroke as confirmed by medical records
- Upper extremity weakness (hemiparesis) contralateral to the stroke
- Sufficient cognitive capacity (Montreal Cognitive Assessment ≥ 21 points), communication function, and English proficiency to understand and safely comply with all study procedures
- Ipsilesional motor-evoked potential response
- Able to perform isometric grip task by making a fist with their stroke-affected hand (hand contralateral to the stroke)
Who cannot join
- Contraindications to TMS (seizure activity within past 2 years, pregnancy, indwelling metal)
- Cognitive deficits (Montreal Cognitive Assessment < 21 points)
- Concurrent physical/occupational therapy and/or clinical trial participation related to stroke
- Injury or conditions that impact affected extremity-use beyond stroke (e.g., arthritis)
- Impaired vision despite use of aid (e.g. glasses, contacts, etc.)
- Cerebellar stroke
- Major medical/neurological/psychiatric condition impacting physical function in the opinion of the physician co-investigator
- Absent ipsilesional motor-evoked potential response
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bondurant Hall
Chapel Hill, North Carolina, 27514
Jessica M Cassidy, PT, DPT, PhD, 919-843-5774, jcassidy@med.unc.edu
About this study
Official title: Modulation of Beta Oscillatory Rhythms in Stroke to Promote Corticomuscular Circuit Function
The goal of this research study is to examine communication between brain and muscle in individuals with stroke and determine if applying non-invasive brain stimulation to different parts of the brain improves this communication and performance on a hand squeezing task.
The investigators will fit participants with an electroencephalography (EEG) cap and place electromyography (EMG) stickers on participants hand and arm muscles to record brain and muscle activity, respectively.
Participants will complete a single research visit lasting approximately 3 hours. During this visit, participants will receive two different types of non-invasive brain stimulation: [1] stimulation to the motor part of the brain and [2] stimulation to the visual part of the brain. Participants will be randomized so that half will receive stimulation to the motor part of the brain first followed by stimulation to the visual part of the brain second and vice versa. Participants will complete three blocks of hand squeezing trials using the stroke-affected (weak) hand. During the first block of squeezing trials, no brain stimulation will occur. During the second and third blocks, participants will receive stimulation just before each hand squeezing trial. The investigators will record participants' brain and muscle activity during these blocks of hand squeezing trials. Additionally, participants will also complete screening tests and exams looking at mood, motor function, and cognition.
Read the detailed description
The purpose of this pilot study is to investigate and modulate corticomuscular coherence (CMC) by using beta-burst repetitive transcranial magnetic stimulation (rTMS). The central hypothesis is that the enhancement of neural oscillatory rhythms in the beta frequency range (13-30 Hz), which supports corticomuscular circuit function, will strengthen CMC measurement. Prior research has indicated that CMC, a surrogate measure of functional connectivity between the brain and peripheral muscles, has clinical relevance as a potential biomarker for motor recovery following stroke. In this cross-over study, the investigators will enroll 20 participants with chronic (≥ 6 months) stroke to complete a single research visit. The investigator will examine corticomuscular circuit function in response to beta-burst repetitive transcranial magnetic stimulation (rTMS) delivery to either participants' ipsilesional motor hotspot (active site) or ipsilesional occipital cortex (control site). The sequence or order of brain stimulation to the active and control site will be randomized across participants (described further below).
Participants will perform three blocks of a precision grip task with their stroke-affected (weak) hand using a custom-built dynamometer device. Each block will contain 20 trials for a total of 60 trials. Participants will receive visual cues when to squeeze the dynamometer device and when to relax their hand. They will also receive visual feedback of their force output to a visual target, which corresponds to 20% of their maximum voluntary contraction force. Prior to the start of these three blocks, participants will be randomized to a rTMS sequence (AB or BA). The first block of 20 trials does not involve stimulation delivery. Participants randomized to the AB sequence will receive rTMS stimulation to a "decoy" or active control site (ipsilesional occipital cortex) during the second block of 20 trials followed by stimulation to the active site (ipsilesional motor hotspot around primary motor cortex, M1) during the third block of 20 trials. Those randomized to the BA sequence will start with stimulation to the active site (M1) during the second block followed by stimulation to the ipsilesional occipital cortex during the third block. Stimulation will occur as a "burst" delivered just prior to the start of each grip trial that is the time just before participant's receive the visual cue to initiate the squeeze.
The investigators will also determine how the degree of injury to the ipsilesional corticospinal tract impacts responsively to beta-burst rTMS. The investigators will assess corticospinal excitability using single transcranial magnetic stimulation pulses to measure the downstream motor-evoked potential (MEP) response. Lastly, investigators will also determine if beta-burst rTMS impacts motor performance as assessed by reaction time and grip precision. The hypotheses are as follows:
- greater pre/post change in CMC following beta-burst rTMS to the active brain site (M1/motor hotspot region) compared to the active control site (ipsilesional occipital cortex)
- those with greater corticospinal tract injury, as denoted by reduced MEP amplitude and increased MEP latency, will demonstrate less pre-post change in CMC
- beta-burst rTMS to the active site (M1/motor hotspot region) will result in improved grip task performance based on reduced reaction times and improved grip precision in comparison rTMS delivery to the ipsilesional occipital cortex (active control site).
- Conditions
- Stroke
- Being tested
- Motor Brain Stimulation, Visual Brain Stimulation
- Keywords
- stroke, neurostimulation, brain, motor, hand, electroencephalography
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Brain StimulationOther
For each grip trial (20 grip trials per block), participants will receive visual cues that signify the onset and offset of squeezing. Just prior to the start of the visual cue representing the onset of squeezing, participants will receive a burst of repetitive transcranial magnetic stimulation (rTMS) to their primary motor hotspot region. Motor brain stimulation will involve 3 bursts of 5 pulses/burst with a 20 Hz inter-pulse interval delivered at 90% of their resting or active motor threshold.
Visual Brain StimulationOther
Also called Active Control Site, Decoy Site
For each grip trial (20 grip trials per block), participants will receive visual cues that signify the onset and offset of squeezing. Just prior to the start of the visual cue representing the onset of squeezing, participants will receive a burst of repetitive transcranial magnetic stimulation (rTMS) to their ipsilesional occipital cortex region. Visual brain stimulation will involve 3 burst of 5 pulses/burst with a 20 Hz inter-pulse interval delivered at 90% of their resting or active motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Motor then Visual Brain Stimulation | Experimental | Following the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "motor then visual brain stimulation" arm will receive stimulation to the motor part of their brain first followed by non-invasive brain stimulation to the visual (occipital) part of the brain. A 10-15 min participant break will separate the delivery of motor and visual brain stimulation (i.e., second and third blocks). Receives: Other: Motor Brain Stimulation; Other: Visual Brain Stimulation |
| Visual then Motor Brain Stimulation | Experimental | Following the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "visual then motor brain stimulation" arm will receive stimulation to the visual part of their brain first followed by non-invasive brain stimulation to the motor part of the brain. A 10-15 min participant break will separate the delivery of visual and motor brain stimulation (i.e., second and third blocks). Receives: Other: Motor Brain Stimulation; Other: Visual Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticomuscular Coherence Change
Investigators will compute pre/post changes in brain-muscle functional connectivity (i.e., corticomuscular coherence, CMC) following across each block (20 trials/block). Specifically, investigators are focused on CMC in the beta (13-30 Hz) frequency range between the ipsilesional motor cortex (M1) and the affected first dorsal interossei muscle. Investigators will calculate CMC at two distinct phases during the squeezing task that correspond to the ramp/recruitment phase (i.e., squeezing to the target) and the hold/sustain phase (when participant's reach the target and sustain their grip).
Measured: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
Grip Precision
The variance of participants' force output from a visual target
Measured: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
Reaction Time
The time delay between the grip signal onset (visual cue provided to participants) and the realized force.
Measured: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, two-sequence (AB I BA), two-treatment crossover study design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jessica M Cassidy, DPT, PT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121582
- Sponsor's protocol ID
- 25-1318
- Other IDs
- 1R21HD117319
- Status last verified
- Feb 2026
- First submitted
- 6 Aug 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that support the results will be shared. Data will include: Corticomuscular Coherence Measures, Behavioral Tests/Measures, motor-evoked potential data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Beta Oscillatory Rhythms in Stroke to Promote Corticomuscular Circuit Function
- ClinicalTrials.gov ID
- NCT07121582
- Acronym / sponsor ID
- 25-1318
- Conditions
- Stroke
- Keywords
- stroke, neurostimulation, brain, motor, hand, electroencephalography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 13 Aug 2025 (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 research study is to examine communication between brain and muscle in individuals with stroke and determine if applying non-invasive brain stimulation to different parts of the brain improves this communication and performance on a hand squeezing task.
The investigators will fit participants with an electroencephalography (EEG) cap and place electromyography (EMG) stickers on participants hand and arm muscles to record brain and muscle activity, respectively.
Participants will complete a single research visit lasting approximately 3 hours. During this visit, participants will receive two different types of non-invasive brain stimulation: [1] stimulation to the motor part of the brain and [2] stimulation to the visual part of the brain. Participants will be randomized so that half will receive stimulation to the motor part of the brain first followed by stimulation to the visual part of the brain second and vice versa. Participants will complete three blocks of hand squeezing trials using the stroke-affected (weak) hand. During the first block of squeezing trials, no brain stimulation will occur. During the second and third blocks, participants will receive stimulation just before each hand squeezing trial. The investigators will record participants' brain and muscle activity during these blocks of hand squeezing trials. Additionally, participants will also complete screening tests and exams looking at mood, motor function, and cognition.
Detailed description
The purpose of this pilot study is to investigate and modulate corticomuscular coherence (CMC) by using beta-burst repetitive transcranial magnetic stimulation (rTMS). The central hypothesis is that the enhancement of neural oscillatory rhythms in the beta frequency range (13-30 Hz), which supports corticomuscular circuit function, will strengthen CMC measurement. Prior research has indicated that CMC, a surrogate measure of functional connectivity between the brain and peripheral muscles, has clinical relevance as a potential biomarker for motor recovery following stroke. In this cross-over study, the investigators will enroll 20 participants with chronic (≥ 6 months) stroke to complete a single research visit. The investigator will examine corticomuscular circuit function in response to beta-burst repetitive transcranial magnetic stimulation (rTMS) delivery to either participants' ipsilesional motor hotspot (active site) or ipsilesional occipital cortex (control site). The sequence or order of brain stimulation to the active and control site will be randomized across participants (described further below).
Participants will perform three blocks of a precision grip task with their stroke-affected (weak) hand using a custom-built dynamometer device. Each block will contain 20 trials for a total of 60 trials. Participants will receive visual cues when to squeeze the dynamometer device and when to relax their hand. They will also receive visual feedback of their force output to a visual target, which corresponds to 20% of their maximum voluntary contraction force. Prior to the start of these three blocks, participants will be randomized to a rTMS sequence (AB or BA). The first block of 20 trials does not involve stimulation delivery. Participants randomized to the AB sequence will receive rTMS stimulation to a "decoy" or active control site (ipsilesional occipital cortex) during the second block of 20 trials followed by stimulation to the active site (ipsilesional motor hotspot around primary motor cortex, M1) during the third block of 20 trials. Those randomized to the BA sequence will start with stimulation to the active site (M1) during the second block followed by stimulation to the ipsilesional occipital cortex during the third block. Stimulation will occur as a "burst" delivered just prior to the start of each grip trial that is the time just before participant's receive the visual cue to initiate the squeeze.
The investigators will also determine how the degree of injury to the ipsilesional corticospinal tract impacts responsively to beta-burst rTMS. The investigators will assess corticospinal excitability using single transcranial magnetic stimulation pulses to measure the downstream motor-evoked potential (MEP) response. Lastly, investigators will also determine if beta-burst rTMS impacts motor performance as assessed by reaction time and grip precision. The hypotheses are as follows:
- greater pre/post change in CMC following beta-burst rTMS to the active brain site (M1/motor hotspot region) compared to the active control site (ipsilesional occipital cortex)
- those with greater corticospinal tract injury, as denoted by reduced MEP amplitude and increased MEP latency, will demonstrate less pre-post change in CMC
- beta-burst rTMS to the active site (M1/motor hotspot region) will result in improved grip task performance based on reduced reaction times and improved grip precision in comparison rTMS delivery to the ipsilesional occipital cortex (active control site).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, two-sequence (AB I BA), two-treatment crossover study design.
| Arm | Type | Receives |
|---|---|---|
| Motor then Visual Brain Stimulation | Experimental | Other: Motor Brain Stimulation, Other: Visual Brain StimulationFollowing the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "motor then visual brain stimulation" arm will receive stimulation to the motor part of their brain first followed by non-invasive brain stimulation to the visual (occipital) part of the brain. A 10-15 min participant break will separate the delivery of motor and visual brain stimulation (i.e., second and third blocks). |
| Visual then Motor Brain Stimulation | Experimental | Other: Motor Brain Stimulation, Other: Visual Brain StimulationFollowing the first block of 20 grip/squeeze trials completed without brain stimulation, participants will complete a second and third set of blocks where non-invasive brain stimulation just before each grip trial will occur. Participants randomized to the "visual then motor brain stimulation" arm will receive stimulation to the visual part of their brain first followed by non-invasive brain stimulation to the motor part of the brain. A 10-15 min participant break will separate the delivery of visual and motor brain stimulation (i.e., second and third blocks). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic (≥ 6 months) unilateral cortical/subcortical ischemic or hemorrhagic stroke as confirmed by medical records
- Upper extremity weakness (hemiparesis) contralateral to the stroke
- Sufficient cognitive capacity (Montreal Cognitive Assessment ≥ 21 points), communication function, and English proficiency to understand and safely comply with all study procedures
- Ipsilesional motor-evoked potential response
- Able to perform isometric grip task by making a fist with their stroke-affected hand (hand contralateral to the stroke)
Key exclusion criteria (8 listed)
- Contraindications to TMS (seizure activity within past 2 years, pregnancy, indwelling metal)
- Cognitive deficits (Montreal Cognitive Assessment < 21 points)
- Concurrent physical/occupational therapy and/or clinical trial participation related to stroke
- Injury or conditions that impact affected extremity-use beyond stroke (e.g., arthritis)
- Impaired vision despite use of aid (e.g. glasses, contacts, etc.)
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 |
|---|---|---|
| Motor Brain StimulationFor each grip trial (20 grip trials per block), participants will receive visual cues that signify the onset and offset of squeezing. Just prior to the start of the visual cue representing the onset of squeezing, participants will receive a burst of repetitive transcranial magnetic stimulation (rTMS) to their primary motor hotspot region. Motor brain stimulation will involve 3 bursts of 5 pulses/burst with a 20 Hz inter-pulse interval delivered at 90% of their resting or active motor threshold. | Other | Motor then Visual Brain Stimulation, Visual then Motor Brain Stimulation |
| Visual Brain StimulationAlso: Active Control Site, Decoy SiteFor each grip trial (20 grip trials per block), participants will receive visual cues that signify the onset and offset of squeezing. Just prior to the start of the visual cue representing the onset of squeezing, participants will receive a burst of repetitive transcranial magnetic stimulation (rTMS) to their ipsilesional occipital cortex region. Visual brain stimulation will involve 3 burst of 5 pulses/burst with a 20 Hz inter-pulse interval delivered at 90% of their resting or active motor threshold. | Other | Motor then Visual Brain Stimulation, Visual then Motor Brain Stimulation |
Primary outcome
Corticomuscular Coherence Change
Time frame: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
Investigators will compute pre/post changes in brain-muscle functional connectivity (i.e., corticomuscular coherence, CMC) following across each block (20 trials/block). Specifically, investigators are focused on CMC in the beta (13-30 Hz) frequency range between the ipsilesional motor cortex (M1) and the affected first dorsal interossei muscle. Investigators will calculate CMC at two distinct phases during the squeezing task that correspond to the ramp/recruitment phase (i.e., squeezing to the target) and the hold/sustain phase (when participant's reach the target and sustain their grip).
Grip Precision
Time frame: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
The variance of participants' force output from a visual target
Reaction Time
Time frame: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
The time delay between the grip signal onset (visual cue provided to participants) and the realized force.
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 27 Apr 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that support the results will be shared. Data will include: Corticomuscular Coherence Measures, Behavioral Tests/Measures, motor-evoked potential data.
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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.
Jessica M Cassidy, DPT, PT, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Brain Stimulation and Visual Brain Stimulation in people with Stroke, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 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 United States. 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. 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 Jessica M Cassidy, DPT, PT, PhD (919-966-8404, CassidyLab@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticomuscular Coherence Change (time frame: Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.). The study lists 3 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 27 Apr 2026.