Q Therapeutic System for Chronic Stroke Recovery

This study is testing a medical device called the Q Therapeutic System (BQ 3.0) for people who have had a stroke. The device uses very low-intensity electromagnetic fields to stimulate brain networks, hoping to improve recovery and reduce disability. You might be able to join if you are between 18 and 80 years old, had a stroke (ischemic or hemorrhagic) 6 months to 5 years ago, and have some arm weakness. The main goal is to see if the BQ 3.0 System can improve how well you use your arm and hand, as measured by a test called the Fugl-Meyer Assessment - Upper Extremity. The study is currently unclear on its recruitment status.

Study design
This is a single-arm, open-label study, meaning all 25 participants will receive the Q Therapeutic System. It is a single-center trial, and the phase is not specified.
What's involved
You would have 5 sessions per week for 3 months (12 weeks), totaling up to 60 sessions. Each session lasts up to 60 minutes, including 40 minutes of device stimulation paired with arm exercises.
Compensation
Not stated in the trial record.
Follow-up
Your arm function will be measured at the beginning of the study, and then again at 3 months, 5 months, and 6 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06979466

Q Therapeutic System for Chronic Stroke Recovery

Recruiting
NAAges 18–80InterventionalTreatment
Burke Rehabilitation Hospital
~25 participants
Updated 2025-08-12 on ClinicalTrials.gov
What's tested:Q Therapeutic System (BQ 3.0) - Active

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl-Meyer Assessment - Upper Extremity
Measured over Baseline, 3 month, 5 month, 6 month
Stroke
Hemorrhage
Brain Injury
Cerebrovascular Accident (CVA)
Chronic Stroke Patient

NCT06979466

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Burke Rehabilitation Hospital

    White Plains, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

FMA-UE score between 22-50 (inclusive) of impaired limb.
Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
Age 18 to 80 years of age (inclusive).
Stroke due to ischemia or to intracerebral hemorrhage.
\>6 months to 5 years from index stroke onset.
Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
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 able to assist during study treatment sessions and visits.
If female, not pregnant or breastfeeding or planning pregnancy during the study period.
Informed consent signed by subject.

Exclusion

Severe neglect impairment interfering with assessments or treatments.
Severe depression, defined as GDS Score \>10/15
The presence of MR-incompatible implanted devices or MR-incompatible retained objects; 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 UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
Pre-existing neurological condition (eg, 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 (eg, 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 interventional trial that would conflict with the current study or clinical endpoint interference may occur.
Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
Employee of the Sponsor.
Prisoner.
  • Fugl-Meyer Assessment - Upper ExtremityBaseline, 3 month, 5 month, 6 month

    a standardized, performance-based measure used to assess motor impairment in the upper limb following stroke or other neurological injuries