The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.

NCT07499310 | Not Yet Recruiting FDA Device

• 1 other identifier: R-1296-25
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures. Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability. Aim 2: Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

Conditions

Stroke; Chronic Stroke Patients

Keywords

BrainQ Electromagnetic Stimulation; upper extremity; rehabilitation; exercise mobility

Outcome Measures

Primary Outcomes (1)

• Mean change of FMA-UE score

  Mean change of FMA-UE score from Baseline to the 3-months follow-up visit. 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

Secondary Outcomes (1)

• Safety endpoints: Cumulative incidence of adverse events

  Initial consent to final study visit (6 months)

Study Arms (1)

Intervention/Treatment

EXPERIMENTAL

Participants will complete 5-7 treatment sessions per week over a 12-week period, with no more than one session per day. Up to the first seven sessions will be conducted at Kessler Foundation, after which the remaining sessions will be performed at home with caregiver assistance as needed. Each session will last up to 60 minutes, including up to 40 minutes with the stimulation field active. During each session, participants will engage in guided physical exercise activities delivered through an app while wearing the BQ device on the head (see image below). Participants who wish to continue beyond the initial 3-month period may opt to extend treatment for an additional 8 weeks, following a similar schedule of 5-7 sessions per week.

Device: Experimental (Q Therapeutic System (BQ 3.0)

Interventions

Experimental (Q Therapeutic System (BQ 3.0) DEVICE

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

Intervention/Treatment

Eligibility Criteria

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

You may qualify if:

• Be between ages 18-80
• Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
• Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
• Have stroke due to ischemia or to intracerebral hemorrhage • Be \>6 months to 5 years from stroke onset
• Have a Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit
• Be able to sit with the investigational System for 40 consecutive minutes
• Be able to follow a 3-step command in English, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent
• Have the willingness to participate in physical exercises during study intervention sessions.
• Be sure of the availability of a relative, friend, or other non-hired caregiver to be able to assist during program sessions and study visits, as needed

You may not qualify if:

• Be younger than 18 years old or older than 80
• Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
• Have conditions other than stroke, such as:
• A. Severe neglect impairment interfering with assessments or treatments. B. Severe depression, defined as GDS Score \>10/15 C. 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.
• D. Severe upper extremity spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score ≥3 in either biceps or chest muscles.
• E. Pre-existing neurological condition (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with my participation in the study and/or confound neurological or functional evaluation F. Unstable serious illness/condition (such as active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with my participation in the study and/or confoundneurological or functional evaluation
• Have alcohol abuse and/or drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial
• Had active participation in an arm rehabilitation program with a therapist in the 4 weeks prior to the screening visit
• Plan to have an arm rehabilitation program with a therapist between the screening visit and the assessment visit at 3-months
• Be an employee of Kessler Foundation
• Be a prisoner
• Be pregnant or breastfeeding or planning pregnancy during the study period.
• Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate

Sponsors & Collaborators

• Kessler Foundation: lead
• BrainQ Technologies Ltd.: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ghaith J Androwis, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghaith J. Androwis, PhD

CONTACT

201-968-6110; GAndrowis@kesslerfoundation.org

Steven Kirshblum, MD

CONTACT

skirshblum@selectmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03