Recruiting

Q Therapeutic

Sponsor:

Burke Rehabilitation Hospital

Code:

NCT06979466

Conditions

Stroke

Hemorrhage

Brain Injury

Cerebrovascular Accident (CVA)

Chronic Stroke Patient

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Q Therapeutic System (BQ 3.0) - Active

Study Details

Brief summary:

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

Hemorrhage

Brain Injury

Cerebrovascular Accident (CVA)

Chronic Stroke Patient

Study ID

NCT06979466

Start date

May 26, 2025

Status verified date

Aug, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • FMA-UE score between 22-50 (inclusive) of impaired limb.
  • Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
  • Age 18 to 80 years of age (inclusive).
  • Stroke due to ischemia or to intracerebral hemorrhage.
  • >6 months to 5 years from index stroke onset.
  • Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
  • 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 able to assist during study treatment sessions and visits.
  • If female, not pregnant or breastfeeding or planning pregnancy during the study period.
  • Informed consent signed by subject.

Exclusion Criteria:

  • Severe neglect impairment interfering with assessments or treatments.
  • Severe depression, defined as GDS Score >10/15
  • The presence of MR-incompatible implanted devices or MR-incompatible retained objects; 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 UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
  • Pre-existing neurological condition (eg, 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 (eg, 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 interventional trial that would conflict with the current study or clinical endpoint interference may occur.
  • Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
  • Employee of the Sponsor.
  • Prisoner.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BQ 3.0 Active Stimulation Group

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.

Interventions

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

Primary outcome measure

  • Fugl-Meyer Assessment - Upper Extremity [ Time Frame: Baseline, 3 month, 5 month, 6 month ]

Central Contacts and Locations

Central contacts

Josette Hartnett, MPH

9145972367johartnett@burke.org

Andrew Abdou, DO

7327137373aabdou@montefiore.org

Locations

Burke Rehabilitation Hospital

Recruiting

White Plains, New York, United States, 10605

Contacts

Josette Hartnett, MPH

9142756481johartnett@burke.org

Andrew Abdou, DO

7327137373aabdou@montefiore.org

Principal Investigator:

Andrew Abdou, DO

More Information

Sponsor

Burke Rehabilitation Hospital

Last update posted

Aug 12, 2025

Last verified

Aug, 2025

Keywords

  • BrainQ
  • Stroke
  • Cerebrovascular Disorders
  • Electromagnetic Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Burke Rehabilitation Hospital on 2025-08-12.