Brain Computer Interface Technology for Emagine Stroke Recovery - Medical / Health Care
This website is designed to assist patients, family members, and caregivers in obtaining valuable information about the EMAGINE study, and to support the process of eligibility evaluation, and research study enrollment for potential participants. The BQ 2.0 system (designed and manufactured by BrainQ Technologies Ltd.) is an investigational device, meaning it has not been approved by the FDA, the use of which has had no related adverse events to date.
Details
The investigational BQ 2.0 system has received Breakthrough Device Designation from the FDA. BrainQ is the sponsor of the Electromagnetic Field Ischemic Stroke – Novel Subacute Treatment (EMAGINE) trial, investigating the use of the BQ 2.0 device ELF-EMF for treating ischemic stroke.
EMAGINE Study Objectives
The pivotal study, launched in November 2021, is a double-blind sham-controlled randomized trial conducted in multiple US sites. The trial evaluates BrainQ’s BQ 2.0, frequency-tuned electromagnetic field treatment in facilitating recovery in individuals with moderate to severe disability following ischemic stroke.
The EMAGINE Stroke Recovery Trial provides a unique care model that enables treatment in both a clinical facility, and a home setting. The study aims to enroll participants 4 to 21 days following a stroke. The study is designed to allow participants to receive the BQ therapy in multiple settings, including acute care facilities, inpatient rehabilitation, and at home. The BQ 2.0 system is operated by a designated caregiver (following initial training sessions with a member from the BrainQ study team), with some oversight by a therapist, who may join at times by a video/audio call to supervise the session.
The trial includes 45 sessions, administered five times a week over nine weeks. Each session will last for 60 minutes, 40 minutes of which will include exposure to BQ therapy, and subjects will be asked to perform a device guided physical therapy exercise regimen. This regimen is in line with the neurorehabilitation guidelines for stroke patients, which state that patients should participate in a home-based rehabilitation program to supplement usual care. Investigational therapy does not in any way replace the usual care.
BrainQ Technologies, the sponsor, maintains this website to help patients get basic information about the study.
When at home, the BQ 2.0 system is operated by a designated caregiver (following initial training sessions with a member from the BrainQ study team), with occasional oversight by a therapist, who will join by a video/audio call to supervise the session.
If you want to participate in the EMAGINE trial, please review our pre-screening questionnaire and consider sharing your contact details so that someone from the EMAGINE team can contact you directly
The EMAGINE study runs in selected medical centers across the US. An updated list of these centers and their contact information can be accessed at the following link:
Reference to the EMAGINE trial on clinicaltrials.gov
If you’re unable to reach a study center or for any further information - please leave your contact info in the “contact us” section.
This study aims to investigate the effect of the BQ therapy on regaining a patient’s independence and reducing their global disability following an Ischemic stroke.
The treatment aspires to utilize the ideal window for recovery in the first few weeks following a stroke. Treatment begins 4 to 21 days post-stroke and therapy is administered five times a week over the course of 9 weeks.Each therapy session is coupled with a device guided physical/occupational therapy regimen that is in line with the stroke rehabilitation guidelines, which recommends that patients with stroke participate in a home-based rehabilitation program to supplement usual care. In this study, there are 60-minute arm and leg physical and occupational therapy (PT/OT) sessions that are recommended to be completed while wearing the BQ 2.0 device (and 20 minutes without the device) with your caregiver. The PT/OT session is guided by the BQ app.
The sessions may be conducted in either inpatient, or outpatient setting. For patients with a significant stroke, it is recommended to participate in home-rehabilitation to supplement usual care (Winstein et al., 2016)
Designated caregivers will receive a short training session on how to operate the BQ 2.0 device, and will then be able to assist the patient and manage the treatment sessions. Sessions will be periodically supervised by dedicated site personnel, who are available to guide the caregiver and patient as needed.
Sessions can be conducted in almost any setting and at any time, and require only a few minutes of preparation. During the sessions, the caregiver will be in charge of putting on and removing the device, operating an easy to use BQ application, and assisting the patient in performing device-guided exercises.
The BQ device has been designed to blend into a patient's daily life, with minimal interference to their daily schedule (one 1-hour session per day).
The BQ device is lightweight, and designed for maximum comfort and ease of use for both patient and caregiver. The device comes with a trolley which is portable, easy to store, and holds all the equipment necessary to perform the BQ therapy session successfully (such as mobile device and battery).
