The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE EMAGINE STUDY)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 80
Healthy Volunteers: No
View:

• mRS score of 3 or 4.

• FMA-UE score between 10-45 (inclusive) of impaired limb.

• Age 22 to 85 years of age (inclusive).

• Diagnosed with an ischemic stroke, confirmed by CT or MRI imaging.

• 4 to 21 days from stroke onset (or last known well).

• Pre-stroke mRS of 0 or 1.

• Able to sit with the investigational device for 40 consecutive minutes.

• Can follow a 3-step command, such as take the paper, fold it in half, and return it to me.

• Willingness to participate in occupational/physical therapy activities during study intervention sessions.

• Availability of a relative or other caregiver able to assist during PT/OT treatment delivered via video call sessions during the study.

• If female, not pregnant (as confirmed by a urine or a blood test, or as determined by an official medical document) or breastfeeding and with no ability to become pregnant or on an acceptable method of contraception during the study

• Informed consent signed by subject (if competent) or legally authorized representative.

Locations
United States
California
Ronald Reagan UCLA Medical Center & California Rehabilitation Institute
Not yet recruiting
Los Angeles
Washington, D.c.
MedStar National Rehabililtaion Hospital,
Recruiting
Washington
Florida
Brooks Rehabilitation Hospital - University Campus
Recruiting
Jacksonville
The Miami Project to Cure Paralysis
Not yet recruiting
Miami
Illinois
Shirley Ryan Abilitylab
Recruiting
Chicago
Kansas
KU Medical Center
Recruiting
Kansas City
Massachusetts
Spaulding Rehabilitation Hospital
Recruiting
Boston
North Carolina
Atrium Health Carolinas Rehabilitation
Recruiting
Charlotte
New Jersey
Kessler Institute of Rehabilitation
Recruiting
West Orange
New York
NYP Brooklyn Methodist Hospital Outpatient Rehabilitation
Recruiting
Brooklyn
Pennsylvania
Moss Rehabilitation Research Institute
Not yet recruiting
Elkins Park
Texas
Baylor Scott & White Institute for Rehabilitation
Not yet recruiting
Dallas
TIRR Memorial Hermann Hospital
Not yet recruiting
Houston
Contact Information
Primary
Assaf Lifshitz
assaf@brainqtech.com
972 54 4586787
Time Frame
Start Date: December 4, 2021
Estimated Completion Date: March 31, 2024
Participants
Target number of participants: 78
Treatments
Sham Comparator: BQ 2.0 sham stimulation group
45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Active Comparator: BQ 2.0 active stimulation group
45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with BQ 2.0 including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Authors
Steven Kirshblum, Richard Zorowitz, Ning Cao, Matthew Shall, Sean Savitz, Jeffrey L Saver, Pamela W Duncan, Joel Stein, Sandra Billinger, Michael Su, Mersedeh Bahr Hosseini, Randie Black-Schaffer, Emily Fox, Simon Driver, Eliot Roth, Ning Chao
Related Therapeutic Areas
Sponsors
Leads: BrainQ Technologies Ltd.

This content was sourced from clinicaltrials.gov

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