Q Therapeutic System for Stroke
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new wearable device called the Q Therapeutic System (BQ 3.0), which uses gentle electromagnetic fields to aid recovery from ischemic strokes (strokes caused by blocked blood vessels in the brain). The goal is to determine if this device can reduce disability and improve recovery when used alongside regular treatments. Participants will receive either active therapy with the device or a sham (inactive) version for comparison. The trial seeks individuals who have experienced an ischemic stroke in the past 4 to 21 days and are facing certain levels of movement difficulty. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative stroke recovery technology.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking anti-epileptic medication, you cannot participate in the trial.
What prior data suggests that the Q Therapeutic System (BQ 3.0) is safe for use in stroke recovery?
Previous studies have shown that the Q Therapeutic System (BQ 3.0) is safe and well-tolerated. Research indicates that this device, which uses gentle electromagnetic fields to aid brain recovery after a stroke, did not cause any treatment-related side effects. Participants in these studies reported no harmful effects from using the device. This suggests that the BQ 3.0 is generally safe for people recovering from a stroke.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach for treating ischemic stroke using electromagnetic fields. Unlike conventional treatments like clot-busting drugs or mechanical thrombectomy, which directly address blood clots, this method uses the Q Therapeutic System (BQ 3.0) to potentially enhance recovery through electromagnetic stimulation. This technique could offer a non-invasive way to improve brain function and promote rehabilitation when combined with physical and occupational therapy. If successful, this approach could provide a new avenue for stroke recovery, especially in the subacute phase, offering hope for improved outcomes.
What evidence suggests that the Q Therapeutic System (BQ 3.0) is effective for neurorecovery after a stroke?
Research has shown that the Q Therapeutic System (BQ 3.0) could aid stroke recovery. Earlier studies examined its ability to reorganize brain connections and enhance movement in stroke survivors. The results suggest that this device might reduce disability over time. In this trial, participants will be divided into two groups: one receiving active stimulation with the BQ 3.0 and the other receiving sham stimulation. Researchers will assess improvements in recovery at specific intervals, such as 45, 90, and 180 days post-stroke. The BQ 3.0 uses gentle electromagnetic fields to stimulate brain activity and support recovery.12367
Who Is on the Research Team?
Jeffrey L. Saver, MD
Principal Investigator
Coordinating PI
Joel Stein, MD
Principal Investigator
Coordinating PI
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 Treatment
Participants receive either active or sham electromagnetic field treatments, 5 times a week, for a total of 45 to 72 sessions.
Stage 2 Treatment
Participants continue with active electromagnetic field treatments, up to 5 times a week, if they completed at least 35 sessions in Stage 1.
Stage 3 Follow-up
Participants are monitored for long-term outcomes without receiving treatments.
What Are the Treatments Tested in This Trial?
Interventions
- Q Therapeutic System (BQ 3.0)
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Q Therapeutic System (BQ 3.0) active stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 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.
Q Therapeutic System (BQ 3.0) sham stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 3.0 (frequency and intensity parameters will be set to zero so that no stimulation is delivered) including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BrainQ Technologies Ltd.
Lead Sponsor
Citations
NCT07095920 | RESPARK - Brain Q for Chronic Stroke
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 ...
Study Details | NCT06386874 | EMAGINE 2.0
Q Therapeutic System (BQ 3.0) active stimulation group: Device used: Q ... To show that the BQ therapy is effective in reducing depression, at 3 months ...
Research Examines Electromagnetic Device to Improve ...
At 45, 90, and 180 days after the stroke, researchers will assess whether the Q Therapeutic System has improved patients' outcomes and record ...
4.
ctv.veeva.com
ctv.veeva.com/study/trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-1108Q Therapeutic System for Chronic Stroke Recovery
Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as ...
Q Therapeutic System for Stroke
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 ...
Electromagnetic Stimulation to Reduce Disability After ...
This randomized clinical trial examines whether electromagnetic network targeting field therapy accompanied by a guided physical and ...
Frequency-tuned electromagnetic field therapy improves ...
No treatment-related adverse events were reported. Conclusions: ENTF stimulation in subacute ischemic stroke patients was associated with improved UE motor ...
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