RESPARK: BrainQ (BQ 3.0) wearable therapy for chronic stroke recovery

Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke

This trial will test whether wearing the BrainQ Q Therapeutic (BQ 3.0) device during guided arm exercises helps people 6 months to 5 years after stroke improve arm and balance function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT07095920 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, single-center trial delivering frequency-tuned, extremely-low-intensity electromagnetic stimulation via the wearable BQ 3.0 device paired with seated upper-extremity exercises. Participants attend five sessions per week for 12 weeks (up to 60 sessions, with a minimum of 40), each session including 40 minutes of active stimulation plus 20 minutes of additional exercises. Clinical outcome measures for upper-extremity motor function and balance are collected before and after the intervention period to characterize safety, feasibility, and preliminary efficacy. The trial enrolls adults 18–80 years old with chronic ischemic or hemorrhagic stroke occurring 6 months to 5 years prior and moderate upper-extremity impairment.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 years old, 6 months to 5 years post-stroke, with moderate upper-extremity impairment (Fugl-Meyer UE 22–50), able to sit for 40 minutes, perform at least one block on the Box & Block test, follow simple commands, and attend frequent in-person sessions with caregiver support.

Not a fit: Patients with very mild or very severe arm impairment outside the Fugl-Meyer range, those less than 6 months or more than 5 years post-stroke, unable to sit for 40 minutes or perform the exercises, or unable to attend frequent in-person sessions are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could reduce disability and improve arm function and balance in people with chronic stroke.

How similar studies have performed: Early-phase and feasibility studies of low-intensity, frequency-tuned electromagnetic stimulation for stroke show preliminary promise but randomized large-scale evidence is currently limited.

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.

Where this trial is running

Jacksonville, Florida

• Brooks Rehabilitation Clinical Research Center — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Emily Fox, PT, DPT, MHS, PhD — University of Florida & Brooks Rehabilitation
• Study coordinator: Emily J Fox, PT, DPT, MHS, PhD

Conditions Stroke; Chronic Stroke Patients; Cerebrovascular Accident; BrainQ; Electromagnetic Stimulation; upper extremity; rehabilitation; exercise