Q Therapeutic System for Stroke

Overseen By Jennifer Brooke Hoisington, MSPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Anti-epileptics, Botulinum toxin

Disqualifiers: Severe neglect, Severe depression, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new wearable device designed to aid recovery from long-term stroke effects. The device, called Q Therapeutic System (BQ 3.0), uses gentle electromagnetic fields to stimulate the brain and support recovery. The study seeks participants who experienced a stroke more than six months ago, have some control over their affected arm, and can comfortably sit for about 40 minutes. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially benefit from cutting-edge technology.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anti-epileptic medication for a seizure disorder.

What prior data suggests that the Q Therapeutic System (BQ 3.0) is safe for stroke rehabilitation?

Research has shown that the Q Therapeutic System (BQ 3.0) has been tested for safety in aiding stroke recovery. Previous studies aimed to ensure the system's reliability and ease of use for patients. These studies found that the treatment is generally safe, with most people experiencing no serious side effects.

The Q Therapeutic System uses a special type of electromagnetic field to aid brain healing after a stroke. It is wearable and non-invasive, meaning it does not involve surgery or entering the body, which reduces the risk of complications.

In summary, past research suggests that the Q Therapeutic System is safe for stroke recovery, with most patients tolerating the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Q Therapeutic System (BQ 3.0) is unique because it combines active stimulation with a standardized physical and occupational therapy regimen. Unlike traditional stroke treatments that often focus solely on medication or passive rehabilitation, BQ 3.0 offers an innovative approach by integrating active, frequency-adjusted stimulation sessions. This method aims to enhance neuroplasticity and recovery through 60 sessions of targeted stimulation over 12 weeks, potentially speeding up and improving the rehabilitation process. Researchers are particularly excited about this integrated approach as it could provide a more effective and dynamic recovery pathway for stroke patients compared to existing options.

What evidence suggests that the Q Therapeutic System is effective for stroke recovery?

Research has shown that the Q Therapeutic System (BQ 3.0), which participants in this trial will receive, might aid stroke recovery through gentle electromagnetic fields. This system aims to activate brain networks and support healing after a stroke. Early studies suggest that patients using the Q Therapeutic System experience better recovery at 45, 90, and 180 days post-stroke, with improvements in movement and reduced disability. These promising results indicate that this system could be a valuable tool in stroke recovery, though further studies are needed to confirm these findings. ^{1 2 3 4 6}

Who Is on the Research Team?

Emily Fox, PT, DPT, MHS, PhD

Principal Investigator

University of Florida & Brooks Rehabilitation

Are You a Good Fit for This Trial?

This trial is for individuals with chronic stroke looking to improve their motor skills and reduce disability. Participants should be in a stable post-stroke phase, able to give informed consent, and willing to follow the study procedures.

Inclusion Criteria

I am willing to do physical exercises during the study.

I am between 18 and 80 years old.

Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit

Exclusion Criteria

Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial

I have received or expect to receive botulinum toxin in my weak arm within 6 months.

I have severe vision problems from a stroke that can't be fixed and would affect my study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Q Therapeutic (BQ 3.0) System intervention, consisting of 60 sessions over 12 weeks with active stimulation and exercises

12 weeks

5 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Q Therapeutic System (BQ 3.0)

Trial Overview The Q Therapeutic (BQ 3.0) System is being tested. It's a wearable device that uses low-intensity electromagnetic fields aimed at stimulating brain function and aiding recovery after a stroke.

How Is the Trial Designed?

Group I: BQ3.0 Active Stimulation Experimental Treatment 1 Intervention

60 sessions over a period of 12 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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

BrainQ Technologies Ltd.

Industry Sponsor

Trials

4

Recruited

260+

Brooks Rehabilitation

Collaborator

Trials

16

Recruited

1,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07095920

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 ...

2. medstarhealth.org medstarhealth.org/blog/electromagnetic-stroke-recovery

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06386874

Study Details | NCT06386874 | EMAGINE 2.0 To show that the BQ therapy is effective in reducing depression, at 3 months post-stroke, when initiated 4 to 21 days following an ischemic stroke. at 90-day ...

4. ctv.veeva.com ctv.veeva.com/study/trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-1108

Q Therapeutic System for Chronic Stroke Recovery The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 60 sessions.

5. withpower.com withpower.com/trial/phase-stroke-7-2025-0ba40

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 ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840298

Electromagnetic Stimulation to Reduce Disability After ... Conclusion and Relevance This trial found that ENTF therapy is safe. Although the difference between groups was not statistically significant, ...