No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
University of Florida · Other
Who this trial is looking for
This trial is looking for adults with chronic stroke to test a new treatment that helps brain recovery after a stroke. Participants will use a wearable device and engage in physical exercises during the study.
Are You a Good Fit for This Trial?
Must not be takingAnti-epileptic medication
Rules you outActive epilepsySevere heart failureActive major psychiatric condition
You may be able to join if
I am between 18 and 80 years old.
I have had a stroke more than 6 months ago.
I can sit with the device for 40 consecutive minutes.
I can follow simple commands.
I have a caregiver to help me during the study.
I have a Fugl-Meyer score of 22-50 for my affected arm.
I scored at least 1 block on the Box & Block Test with my affected arm.
If I am a woman, I am not pregnant or breastfeeding.
You may not be able to join if
I have severe depression.
I have severe neglect that affects my participation.
I have a serious medical condition affecting my health.
I have an implanted device that is not compatible with MRI.
I have had any seizures in the last 5 years.
I have severe spasticity in my arms.
I have participated in another trial that conflicts with this one.
I have a neurological condition like Parkinson's or Alzheimer's.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 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.
Trial Locations
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Status
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 …
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.
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