Q Therapeutic System for Chronic Stroke Recovery

NCT06979466 | Recruiting FDA Device

• 1 other identifier: BRH_EMAGINE C IIT_202501
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

BrainQ; Stroke; Cerebrovascular Disorders; Electromagnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity

  a standardized, performance-based measure used to assess motor impairment in the upper limb following stroke or other neurological injuries

  Baseline, 3 month, 5 month, 6 month

Secondary Outcomes (10)

• Box and Block Test

  Baseline, 3 month, 5 month, 6 month

• Geriatric Depression Scale (Short Form) (GDS)

  Baseline, 3 month, 5 month, 6 month

• modified Rankin Scale (mRS)

  Baseline, 3 month, 5 month, 6 month

• Stroke Impact Scale (SIS) Hand Domain

  Baseline, 3 month, 5 month, 6 month

• Stroke Impact Scale 16 (SIS-16)

  Baseline, 3 month, 5 month, 6 month

Study Arms (1)

BQ 3.0 Active Stimulation Group

EXPERIMENTAL

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.

Device: Q Therapeutic System (BQ 3.0) - Active

Interventions

Q Therapeutic System (BQ 3.0) - Active DEVICE

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

Also known as: BQ 3.0 Active Stimulation Group Interventions

BQ 3.0 Active Stimulation Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Burke Rehabilitation Hospital: lead
• BrainQ Technologies Ltd.: collaborator

Study Sites (1)

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

RECRUITING

Related Publications (4)

• Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022.

  PMID: 36452175 BACKGROUND

• Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023.

  PMID: 37213907 BACKGROUND

• Segal Y, Segal L, Blumenfeld-Katzir T, Sasson E, Poliansky V, Loeb E, Levy A, Alter A, Bregman N. The Effect of Electromagnetic Field Treatment on Recovery from Ischemic Stroke in a Rat Stroke Model: Clinical, Imaging, and Pathological Findings. Stroke Res Treat. 2016;2016:6941946. doi: 10.1155/2016/6941946. Epub 2016 Feb 1.

  PMID: 26949561 BACKGROUND

• Okabe N, Hovanesyan M, Azarapetian S, Dai W, Weisinger B, Parabucki A, Balter SR, Shohami E, Segal Y, Carmichael ST. Theta Frequency Electromagnetic Stimulation Enhances Functional Recovery After Stroke. Transl Stroke Res. 2025 Apr;16(2):194-206. doi: 10.1007/s12975-023-01202-z. Epub 2023 Nov 14.

  PMID: 37962771 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemorrhage; Brain Injuries; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Josette Hartnett, MPH

CONTACT

9145972367; johartnett@burke.org

Andrew Abdou, DO

CONTACT

7327137373; aabdou@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the efficacy, and safety of the intervention in the management of chronic stroke patients.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be shared from July 2025 to Dec 2026 between the site and study sponsor.
• Access Criteria: De-identified data in excel spreadsheets will me made available to the study sponsor.

Locations

US (1)