The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treat… (NCT07499310) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.
25 participantsStarted 2026-02
Plain-language summary
This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures.
Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability.
Aim 2: Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be between ages 18-80
* Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
* Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
* Have stroke due to ischemia or to intracerebral hemorrhage • Be \>6 months to 5 years from stroke onset
* Have a Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit
* Be able to sit with the investigational System for 40 consecutive minutes
* Be able to follow a 3-step command in English, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent
* Have the willingness to participate in physical exercises during study intervention sessions.
* Be sure of the availability of a relative, friend, or other non-hired caregiver to be able to assist during program sessions and study visits, as needed
Exclusion Criteria:
* Be younger than 18 years old or older than 80
* Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
* Have conditions other than stroke, such as:
A. Severe neglect impairment interfering with assessments or treatments. B. Severe depression, defined as GDS Score \>10/15 C. Active epilepsy o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change of FMA-UE score
Timeframe: Baseline, 3 months after, and 6 months after start of interventions