RECRUITING

RESPARK - Brain Q for Chronic Stroke

Conditions

Stroke Chronic Stroke Patients Cerebrovascular Accident (CVA)BrainQ Electromagnetic Stimulation upper extremity rehabilitation exercise mobility

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke

Quick Facts

Study Start:2025-08-27

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07095920

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb. 2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit. 3. Age 18 to 80 years of age (inclusive). 4. Stroke due to ischemia or to intracerebral hemorrhage. 5. \>6 months to 5 years from stroke onset. 6. Box \& Block Test score with affected arm is ≥1 block in 60 seconds. 7. Able to sit with the investigational system for 40 consecutive minutes. 8. 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. 9. Willingness to participate in physical exercises during study intervention sessions. 10. 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. 11. If female, not pregnant or breastfeeding or planning pregnancy during the study period. 12. The subject is able to provide Informed consent.	1. Severe neglect impairment interfering with assessments or treatments. 2. Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15 3. 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). 4. 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 5. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit 6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis 7. 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. 8. 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. 9. Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. 10. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial. 11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur. 12. 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. 13. Employee of the Sponsor. 14. Prisoner.

Inclusion Criteria

Exclusion Criteria

1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
3. Age 18 to 80 years of age (inclusive).
4. Stroke due to ischemia or to intracerebral hemorrhage.
5. \>6 months to 5 years from stroke onset.
6. Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
7. Able to sit with the investigational system for 40 consecutive minutes.
8. 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.
9. Willingness to participate in physical exercises during study intervention sessions.
10. 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.
11. If female, not pregnant or breastfeeding or planning pregnancy during the study period.
12. The subject is able to provide Informed consent.

1. Severe neglect impairment interfering with assessments or treatments.
2. Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15
3. 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).
4. 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
5. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
7. 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.
8. 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.
9. Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
10. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
12. 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.
13. Employee of the Sponsor.
14. Prisoner.

Contacts and Locations

Study Contact

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

Principal Investigator

Emily Fox, PT, DPT, MHS, PhD

PRINCIPAL_INVESTIGATOR

University of Florida & Brooks Rehabilitation

Study Locations (Sites)

Brooks Rehabilitation Clinical Research Center

Jacksonville, Florida, 32216

United States

Collaborators and Investigators

Sponsor: University of Florida

Emily Fox, PT, DPT, MHS, PhD, PRINCIPAL_INVESTIGATOR, University of Florida & Brooks Rehabilitation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-27

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-08-27

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

BrainQ
Electromagnetic Stimulation
upper extremity
rehabilitation
exercise
mobility

Additional Relevant MeSH Terms

Stroke
Chronic Stroke Patients
Cerebrovascular Accident (CVA)