RESPARK - Brain Q for Chronic Stroke
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- University of Florida
- Study ID
- NCT07095920
- Status
- Recruiting
Conditions
- Cerebrovascular Accident (CVA)
- Chronic Stroke Patients
- Stroke
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Device: Q Therapeutic System (BQ 3.0) - Active — DEVICEThe BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.
Study Details
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.
Key Dates
- Start date
- Aug 27, 2025
- Status verified
- Apr 2026
- Primary completion
- May 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: BQ3.0 Active Stimulation60 sessions over a period of 12 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Primary Outcome Measure
Change in Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline, 3 months after, and 6 months after start of interventions ]
Central Contacts
- Emily J Fox, PT, DPT, MHS, PhD904-742-2500
- Jennifer Brooke Hoisington, MSPT904-659-3733
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brooks Rehabilitation Clinical Research Center | Jacksonville | Florida | 32216 | Emily J Fox, PT, DPT, MHS, PhD (PRINCIPAL_INVESTIGATOR) |
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