| NCT ID | NCT07121582 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 & Investigator
Jessica M Cassidy, DPT, PT, PhD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT07121582 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07121582 currently recruiting?
Yes, NCT07121582 is actively recruiting participants. Contact the research team at CassidyLab@unc.edu for enrollment information.
Where is the NCT07121582 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07121582 clinical trial?
NCT07121582 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Jessica M Cassidy, DPT, PT, PhD at University of North Carolina, Chapel Hill. The trial plans to enroll 20 participants.
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