Modulation of Brain Rhythms in Stroke
Modulation of Beta Oscillatory Rhythms in Stroke to Promote Corticomuscular Circuit Function
2 other identifiers
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Dec 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2025
CompletedFirst Posted
Study publicly available on registry
August 13, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 27, 2026
February 1, 2026
1.1 years
August 6, 2025
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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
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.
Immediately (within 5 minutes) before and after (within 5 minutes) each stimulation block.
Study Arms (2)
Motor then Visual Brain Stimulation
EXPERIMENTALFollowing 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
EXPERIMENTALFollowing 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bondurant Hall
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica M Cassidy, DPT, PT, PhD
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2025
First Posted
August 13, 2025
Study Start
December 1, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be shared no later than 6 months after publication submission with no end date.
- Access Criteria
- Approved Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'s Data and Specimen Hub (DASH).
Deidentified individual data that support the results will be shared. Data will include: Corticomuscular Coherence Measures, Behavioral Tests/Measures, motor-evoked potential data.