StrokeNCT07095920
RESPARK - Brain Q for Chronic Stroke
A study testing Device: Q Therapeutic System (BQ 3.0) - Active in people with Stroke and Chronic Stroke Patients, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Chronic Stroke Patients, Cerebrovascular Accident (CVA)
- What is being tested?
- Device: Q Therapeutic System (BQ 3.0) - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
- Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
- Age 18 to 80 years of age (inclusive).
- Stroke due to ischemia or to intracerebral hemorrhage.
- >6 months to 5 years from stroke onset.
- Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
Show all 12Show fewer
- Able to sit with the investigational system for 40 consecutive minutes.
- 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.
- Willingness to participate in physical exercises during study intervention sessions.
- 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.
- If female, not pregnant or breastfeeding or planning pregnancy during the study period.
- The subject is able to provide Informed consent.
Who cannot join
- Severe neglect impairment interfering with assessments or treatments.
- Severe depression, defined as Geriatric Depression Scale (GDS) Score >10/15
- 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).
- 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
- Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
- Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
Show all 14Show fewer
- 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.
- 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.
- Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
- Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
- Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
- 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.
- Employee of the Sponsor.
- Prisoner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, 32216
About this study
Official title: Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke
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.
Read the detailed description
The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 60 sessions. Each participant must complete at least 40 sessions over the 12-week period to complete the protocol. No extra time will be given to complete all 60 sessions. Each session will last up to 60 minutes during which 40 minutes of active stimulation using the BQ 3.0 System will be administered to participants. The 40 minutes of stimulation will be paired with seated upper extremity (UE) exercises. Lastly, the device will be removed and 10 minutes of standing balance and LE strengthening exercises will be performed without stimulation. A battery of clinical assessments will be conducted before and after the 60 exercise sessions.
- Being tested
- Device: Q Therapeutic System (BQ 3.0) - Active
- Keywords
- BrainQ, Electromagnetic Stimulation, upper extremity, rehabilitation, exercise, mobility
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Q Therapeutic System (BQ 3.0) - ActiveDevice
The 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 group | Role | What they receive |
|---|---|---|
| BQ3.0 Active Stimulation | Experimental | 60 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. Receives: Device: Device: Q Therapeutic System (BQ 3.0) - Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment - Upper Extremity
A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
Measured: Baseline, 3 months after, and 6 months after start of interventions
Change from Baseline in Modified Rankin Scale (mRS)
A 7-point scale used to measure the degree of disability or dependence in daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). A decrease in score reflects a reduction in disability and improved independence.
Measured: Baseline, 3 months after, and 6 months after the start of interventions
Secondary outcomes (1)
Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
Measured: Initial consent through final study visit (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start27 Aug 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- BrainQ Technologies Ltd., Brooks Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Emily Fox, PT, DPT, MHS, PhD, Principal investigator, University of Florida & Brooks Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095920
- Sponsor's protocol ID
- IRB202500526
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified IPD will be shared with the study sponsor.