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NCT06386874 · ClinicalTrials.gov registry record · NA
EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment
A NA study of Ischemic Stroke, sponsored by BrainQ Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 122
- Enrollment target
- 14
- Study locations
NCT06386874 is a NA study of Ischemic Stroke that is actively recruiting participants, run by BrainQ Technologies. The registered enrollment target is 122 participants, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (92% lower). The trial reports 14 study locations across 12 states.
The verdict
NCT06386874, a NA study of Ischemic Stroke, is actively recruiting participants, sponsored by BrainQ Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
- 14
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Q Therapeutic System (BQ 3.0) - Active
- DEVICE Q Therapeutic System (BQ 3.0) - Sham
Study Locations (14)
New Jersey
- Hackensack Meridian JFK Johnson Rehabilitation Institute - Edison
- Kessler Foundation for Rehabilitation - West Orange
New York
- New York-Presbyterian Brooklyn Methodist Hospital Inpatient Rehabilitation Unit - Brooklyn
- Burke Rehabilitation Hospital - White Plains
California
- Rancho Research Institute - Downey
District of Columbia
- MedStar National Rehabililtaion Hospital, - Washington D.C.
Florida
- Brooks Rehabilitation Hospital - Jacksonville
Georgia
- Emory University School of Medicine - Altanta
Illinois
- Shirley Ryan AbilityLab - Chicago
Kansas
- KUMC- KU Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2026-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06386874
The ClinicalTrials.gov registry entry for NCT06386874 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (92% lower). The listed sponsor is BrainQ Technologies, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Q Therapeutic System (BQ 3.0) - Active is the first listed.
NCT06386874 reports 14 study locations spanning 12 distinct geographic areas - top geographies include New Jersey, New York, California.
Frequently Asked Questions
What is clinical trial NCT06386874 about?
NCT06386874 is a clinical study titled "EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment". 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...
What is the current status of trial NCT06386874?
This trial is currently recruiting. It is a NA study. The enrollment target is 122 participants. The study started on 2024-08-20. Estimated completion is 2026-10.
What conditions does trial NCT06386874 study?
This clinical trial studies the following conditions: Ischemic Stroke.
What interventions are being tested in trial NCT06386874?
The interventions under investigation include: Q Therapeutic System (BQ 3.0) - Active (DEVICE), Q Therapeutic System (BQ 3.0) - Sham (DEVICE).
Who is sponsoring clinical trial NCT06386874?
This trial is sponsored by BrainQ Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06386874 being conducted?
This trial has 14 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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