Actively Recruiting
RESPARK - Brain Q for Chronic Stroke
Led by University of Florida · Updated on 2026-05-14
25
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
B
BrainQ Technologies Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RESPARK - Brain Q for Chronic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Upper Extremity Fugl-Meyer Assessment score between 22 and 50 for the affected limb
- Upper Extremity Fugl-Meyer Assessment score within 3 points between Screening and Baseline visits
- Age 18 to 80 years inclusive
- Stroke caused by ischemia or intracerebral hemorrhage
- Stroke occurred more than 6 months and up to 5 years ago
- Box & Block Test score of at least 1 block in 60 seconds with affected arm
- Able to sit for 40 consecutive minutes during device use
- Able to follow a 3-step command or equivalent non-verbal instruction
- Willing to participate in physical exercises during study sessions
- Availability of a caregiver to assist during treatment sessions and at home
- If female, not pregnant, breastfeeding, or planning pregnancy during the study
- Able to provide informed consent
You will not qualify if you...
- Severe neglect interfering with assessments or treatments
- Severe depression defined as Geriatric Depression Scale score above 10 out of 15
- Presence of implanted or retained MR-incompatible devices or life-sustaining MR-compatible devices (e.g., pacemaker)
- Active epilepsy or use of anti-epileptic medication; seizure in last 5 years
- Botulinum toxin treatment to affected arm within 3 months prior or expected before 6-month visit
- Severe upper extremity spasticity with contracture or modified Ashworth Scale score 3 or higher
- Pre-existing neurological conditions (e.g., Alzheimer's, Parkinson's, multiple sclerosis, brain injury, spinal cord injury) or physical limitations interfering with participation
- Significant uncorrected visual disturbances affecting participation
- Unstable serious illness or life expectancy less than 12 months
- Alcohol or illicit drug abuse in past 6 months likely affecting participation
- Participation in conflicting clinical trials
- Active participation in licensed upper extremity rehabilitation within 4 weeks before screening and until primary endpoint
- Employee of the sponsor
- Prisoner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, United States, 32216
Actively Recruiting
Research Team
E
Emily J Fox, PT, DPT, MHS, PhD
CONTACT
J
Jennifer Brooke Hoisington, MSPT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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