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StrokeNCT07095920

RESPARK - Brain Q for Chronic Stroke

A study testing Device: Q Therapeutic System (BQ 3.0) - Active in people with Stroke and Chronic Stroke Patients, run by University of Florida at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Device: Q Therapeutic System (BQ 3.0) - Active
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
27 Aug 2025to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
  • Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
  • Age 18 to 80 years of age (inclusive).
  • Stroke due to ischemia or to intracerebral hemorrhage.
  • >6 months to 5 years from stroke onset.
  • Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
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  • 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 that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.
  • If female, not pregnant or breastfeeding or planning pregnancy during the study period.
  • The subject is able to provide Informed consent.

Who cannot join

  • Severe neglect impairment interfering with assessments or treatments.
  • Severe depression, defined as Geriatric Depression Scale (GDS) Score >10/15
  • Presence of implanted or retained MR-incompatible devices or materials, 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 upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
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  • Pre-existing neurological condition (e.g., 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 (e.g., 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 trial that would conflict with the current study or clinical endpoint interference may occur.
  • Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.
  • Employee of the Sponsor.
  • Prisoner.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brooks Rehabilitation Clinical Research Center

    Jacksonville, Florida, 32216

Other trials in United States

About this study

Official title: Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With 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 medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.

Read the detailed description

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. Each participant must complete at least 40 sessions over the 12-week period to complete the protocol. No extra time will be given to complete all 60 sessions. Each session will last up to 60 minutes during which 40 minutes of active stimulation using the BQ 3.0 System will be administered to participants. The 40 minutes of stimulation will be paired with seated upper extremity (UE) exercises. Lastly, the device will be removed and 10 minutes of standing balance and LE strengthening exercises will be performed without stimulation. A battery of clinical assessments will be conducted before and after the 60 exercise sessions.

Being tested
Device: Q Therapeutic System (BQ 3.0) - Active
Keywords
BrainQ, Electromagnetic Stimulation, upper extremity, rehabilitation, exercise, mobility
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device: Q Therapeutic System (BQ 3.0) - ActiveDevice

    The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.

Study groups in NCT07095920
Study groupRoleWhat they receive
BQ3.0 Active StimulationExperimental60 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.
Receives: Device: Device: Q Therapeutic System (BQ 3.0) - Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Fugl-Meyer Assessment - Upper Extremity

    A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.

    Measured: Baseline, 3 months after, and 6 months after start of interventions

  2. Change from Baseline in Modified Rankin Scale (mRS)

    A 7-point scale used to measure the degree of disability or dependence in daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). A decrease in score reflects a reduction in disability and improved independence.

    Measured: Baseline, 3 months after, and 6 months after the start of interventions

Secondary outcomes (1)

  1. Cumulative incidence of adverse events

    The number of adverse events reported throughout the study.

    Measured: Initial consent through final study visit (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start27 Aug 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07095920
Sponsor's protocol ID
IRB202500526
Status last verified
Oct 2026
First submitted
24 Jul 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified IPD will be shared with the study sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Device: Q Therapeutic System (BQ 3.0) - Active in people with Stroke and Chronic Stroke Patients, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fugl-Meyer Assessment - Upper Extremity (time frame: Baseline, 3 months after, and 6 months after start of interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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RESPARK - Brain Q for Chronic Stroke (NCT07095920) | AzTrials