Health Trials

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

Qualifiers

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

Treatments tested in this trial

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

Treatment groups

25 Participants
are divided into 1 treatment group

Locations

1
Brooks Rehabilitation Clinical Research Center32216, JacksonvilleFlorida, United States

Sponsors and collaborators

University of Florida

Lead sponsor

BrainQ Technologies Ltd.

Collaborator

Brooks Rehabilitation

Collaborator

Source ClinicalTrials.gov