RESPARK - Brain Q for Chronic Stroke

NCT07095920 | Recruiting FDA Device

• 1 other identifier: IRB202500526
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke; Chronic Stroke Patients; Cerebrovascular Accident (CVA)

Keywords

BrainQ; Electromagnetic Stimulation; upper extremity; rehabilitation; exercise; mobility

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Cumulative incidence of adverse events

  Initial consent through final study visit (6 months)

Study Arms (1)

BQ3.0 Active Stimulation

EXPERIMENTAL

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.

Device: Device: Q Therapeutic System (BQ 3.0) - Active

Interventions

Device: Q Therapeutic System (BQ 3.0) - Active DEVICE

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.

BQ3.0 Active Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Florida: lead
• BrainQ Technologies Ltd.: collaborator
• Brooks Rehabilitation: collaborator

Study Sites (1)

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, 32216, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Emily Fox, PT, DPT, MHS, PhD

  University of Florida & Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily J Fox, PT, DPT, MHS, PhD

CONTACT

904-742-2500; ejfox@phhp.ufl.edu

Jennifer Brooke Hoisington, MSPT

CONTACT

904-659-3733; brooke.hoisington@brooksrehab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 27, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be shared from July 2025 to Dec 2026 between the site and study sponsor.
• Access Criteria: De-identified data in excel spreadsheets will me made available to the study sponsor.

Locations

US (1)