Clinical Research Directory
Browse clinical research sites, groups, and studies.
EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment
Sponsor: BrainQ Technologies Ltd.
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
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.
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