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RECRUITING
NCT06386874
NA

EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Sponsor: BrainQ Technologies Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter study that will be conducted at approximately 20 centers and up to 30 centers, if the sample size will be increased following interim assessment. The Q Therapeutic System (BQ 3.0) is a wearable medical device 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. The Q Therapeutic System (BQ 3.0) is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies. * In Stage 1 (starting 4-21 days after the index stroke event to day 90 post stroke), participants will be randomly assigned (1:1) to receive either active or the sham treatments, up to 5 times a week, and at least to a total of 45 treatments. * In Stage 2 (day 90 to day 180 post stroke), participants in both the active and the control group will be allowed to continue to receive active treatments, up to 5 times per week. * In stage 3 (day 180 to day 270 post stroke), participants will not receive any treatments and would be followed up until the final visit at day 270. Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. Treatments may be administered in the hospital, in the clinic or in a home setting. The study will enroll 100-122 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ 3.0 system.

Official title: The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (the "EMAGINE 2.0" Study)

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

122

Start Date

2024-08-20

Completion Date

2026-10

Last Updated

2025-01-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Q Therapeutic System (BQ 3.0) - Sham

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. Frequency and intensity parameters will be set to zero so that no stimulation is delivered.

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

Locations (14)

Rancho Research Institute

Downey, California, United States

MedStar National Rehabililtaion Hospital,

Washington D.C., District of Columbia, United States

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Emory University School of Medicine

Altanta, Georgia, United States

Shirley Ryan AbilityLab

Chicago, Illinois, United States

KUMC- KU Medical Center

Kansas City, Kansas, United States

Hackensack Meridian JFK Johnson Rehabilitation Institute

Edison, New Jersey, United States

Kessler Foundation for Rehabilitation

West Orange, New Jersey, United States

New York-Presbyterian Brooklyn Methodist Hospital Inpatient Rehabilitation Unit

Brooklyn, New York, United States

Burke Rehabilitation Hospital

White Plains, New York, United States

Atrium Health Carolinas Rehabilitation

Charlotte, North Carolina, United States

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States

UTHealth Houston

Houston, Texas, United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States