| NCT ID | NCT07095920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2026-05 |
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 25 participants in total. It began in 2025-08-27 with a primary completion date of 2026-05.
⚠ 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
This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.
Eligibility Criteria
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.
Contact & Investigator
Emily Fox, PT, DPT, MHS, PhD
PRINCIPAL INVESTIGATOR
University of Florida & Brooks Rehabilitation
Frequently Asked Questions
Who can join the NCT07095920 clinical trial?
This trial is open to participants of all sexes, aged 18 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 NCT07095920 currently recruiting?
Yes, NCT07095920 is actively recruiting participants. Contact the research team at ejfox@phhp.ufl.edu for enrollment information.
Where is the NCT07095920 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07095920 clinical trial?
NCT07095920 is sponsored by University of Florida. The principal investigator is Emily Fox, PT, DPT, MHS, PhD at University of Florida & Brooks Rehabilitation. The trial plans to enroll 25 participants.
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