Q Therapeutic System to improve arm and hand function after chronic stroke
Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment
This trial will try the Q Therapeutic (BQ 3.0) electromagnetic stimulation system with guided arm exercises to see if it improves upper limb function in people 6 months to 5 years after a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Burke Rehabilitation Hospital Academic / other |
| Locations | 1 site (White Plains, New York) |
| Trial ID | NCT06979466 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, open-label, single-center trial testing the Q Therapeutic (BQ 3.0) system paired with upper-extremity exercises in people with chronic stroke. Participants are scheduled for up to 60 sessions over 12 weeks (5 sessions per week), each session including 40 minutes of active stimulation with seated arm exercises and 10 minutes of standing balance/leg work without stimulation. Primary outcomes are validated clinical measures of upper-extremity function taken before and after the treatment course, and secondary endpoints include global disability, quality of life, feasibility, and safety. The protocol requires at least 40 completed sessions and uses both in-clinic and at-home sessions with caregiver support.
Who should consider this trial
Good fit: Adults 18–80 who are 6 months to 5 years after an ischemic or intracerebral hemorrhagic stroke with moderate arm impairment (FMA-UE 22–50), able to sit for 40 minutes, follow simple commands, and who have caregiver support are ideal candidates.
Not a fit: People with very mild or very severe arm impairment outside the FMA-UE range, severe neglect that prevents participation, inability to sit or follow commands, or without caregiver support are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could help people with chronic stroke regain meaningful arm and hand function and improve daily activities.
How similar studies have performed: Noninvasive electromagnetic neuromodulation paired with rehabilitation has shown encouraging results in small or pilot studies, but larger controlled trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
White Plains, New York
- Burke Rehabilitation Hospital — White Plains, New York, United States (Recruiting)
Study contacts
- Study coordinator: Josette Hartnett, MPH
- Email: johartnett@burke.org
- Phone: 9145972367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.