Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-08-27
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BQ3.0 Active Stimulation
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.
Device: Q Therapeutic System (BQ 3.0) - Active
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.
Interventions
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Device: Q Therapeutic System (BQ 3.0) - Active
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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BrainQ Technologies Ltd.
INDUSTRY
Brooks Rehabilitation
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Emily Fox, PT, DPT, MHS, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida & Brooks Rehabilitation
Locations
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Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB202500526
Identifier Type: -
Identifier Source: org_study_id
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