RESPARK - Brain Q for Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Device: Q Therapeutic System (BQ 3.0) - Active
DeviceThe 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: BQ3.0 Active StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 3 months after, and 6 months after start of interventions2
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.
Time frame
Baseline, 3 months after, and 6 months after the start of interventionsSecondary outcomes
1
Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
Time frame
Initial consent through final study visit (6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
BrainQ Technologies Ltd.
Collaborator
Brooks Rehabilitation
Collaborator
Source ClinicalTrials.gov