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NCT05044507 · ClinicalTrials.gov registry record · NA
The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)
A NA study of Ischemic Stroke, sponsored by BrainQ Technologies.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 15
- Study locations
NCT05044507: Completed NA study of Ischemic Stroke, sponsored by BrainQ Technologies.
NCT05044507 is a NA study of Ischemic Stroke that has completed, run by BrainQ Technologies. The registered enrollment target is 100 participants, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05044507, a NA study of Ischemic Stroke, has completed, sponsored by BrainQ Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a multicenter study that will be conducted at approximately 20 centers. BQ 2.0 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. In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment. BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT) and periodic supervision (either remote or in person) of a trained site study team member. Treatments may be administered in multiple settings (e.g. acute care hospital (ACH) or inpatient rehabilitation facilities (IRF), Skilled Nursing Facility (SNF), home or other outpatient setup). The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.
Primary Outcome
Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)
Conditions Studied
Interventions
- DEVICE BQ 2.0
Study Locations (15)
California
- Rancho Research Institute - Downey
- Ronald Reagan UCLA Medical Center & California Rehabilitation Institute - Los Angeles
Florida
- Brooks Rehabilitation Hospital - University Campus - Jacksonville
- The Miami Project to Cure Paralysis - Miami
New Jersey
- JFK Johnson Rehabilitation Institute - Edison
- Kessler Institute of Rehabilitation - West Orange
Texas
- Baylor Scott & White Institute for Rehabilitation - Dallas
- TIRR Memorial Hermann Hospital - Houston
District of Columbia
- MedStar National Rehabililtaion Hospital, - Washington D.C.
Illinois
- Shirley Ryan Abilitylab - Chicago
Kansas
- KU Medical Center - Kansas City
Massachusetts
- Spaulding Rehabilitation Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-12-04 |
| Est. Completion | 2024-01-16 |
| Phase | NA |
What the finished NCT05044507 record still lists
NCT05044507 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,462-participant average among 66 other Ischemic Stroke trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Ischemic Stroke appearing as the primary indexed condition, and to 1 intervention - of which BQ 2.0 is the first listed.
NCT05044507 lists 15 locations in 11 states (California, Florida, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05044507 about?
NCT05044507 is a clinical study titled "The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)". This is a multicenter study that will be conducted at approximately 20 centers. BQ 2.0 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 reduc...
What is the current status of trial NCT05044507?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2021-12-04. Estimated completion is 2024-01-16.
What conditions does trial NCT05044507 study?
This clinical trial studies the following conditions: Ischemic Stroke.
What interventions are being tested in trial NCT05044507?
The interventions under investigation include: BQ 2.0 (DEVICE).
Who is sponsoring clinical trial NCT05044507?
This trial is sponsored by BrainQ Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05044507 being conducted?
This trial has 15 study locations across California, District of Columbia, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ischemic Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05044507's enrollment target sits among peer trials
100 32nd of 66 higher than 35 of 66 other Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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