Could a wearable device spark recovery in chronic stroke patients?
NCT ID NCT07095920
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests a wearable device that sends gentle, low-frequency electromagnetic fields to the brain to help people who had a stroke more than 6 months ago recover arm movement and reduce disability. About 25 adults with chronic stroke will use the device in a clinic to see if it is safe and improves arm function. The goal is to find a new way to help the brain rewire itself after a stroke.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb. 2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit. 3. Age 18 to 80 years of age (inclusive). 4. Stroke due to ischemia or to intracerebral hemorrhage. 5. \>6 months to 5 years from stroke onset. 6. Box \& Block Test score with affected arm is ≥1 block in 60 seconds. 7. Able to sit with the investigational system for 40 consecutive minutes. 8. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent. 9. Willingness to participate in physical exercises during study intervention sessions. 10. Availability of a relative or other caregiver that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration. 11. If female, not pregnant or breastfeeding or planning pregnancy during the study period. 12. The subject is able to provide Informed consent. Exclusion Criteria: 1. Severe neglect impairment interfering with assessments or treatments. 2. Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15 3. Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator). 4. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years 5. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit 6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis 7. Pre-existing neurological condition (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation. 8. Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation. 9. Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. 10. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial. 11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur. 12. Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit. 13. Employee of the Sponsor. 14. Prisoner.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brooks Rehabilitation Clinical Research Center
RECRUITINGJacksonville, Florida, 32216, United States
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Other studies related to the condition(s) this trial covers.
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