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

NCT05044507 | Completed DMC FDA Device

• 1 other identifier: BQ5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Ischemic Stroke

Keywords

subacute

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Modified Rankin Scale

  Mean change in mRS score from baseline (post-stroke day 4-21) to 90 days post stroke (90 ±15 days post-stroke)

  change from baseline (4-21 days post stroke) to 90 days post stroke. mRS will be assessed at 90 Day FU visit

Secondary Outcomes (6)

• Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (upper limb function)

  change from baseline (4-21 days post stroke) to 90 days post stroke. FMA-EU will be assessed at 90 Day FU visit

• Change from Baseline in Box and Block Test (fine hand function)

  change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit)

• Change from Baseline in 10 Meter Walk Test (gait speed)

  change from baseline (4-21 days post stroke) to 90 days post stroke. (will be assessed at 90 Day FU visit )

• Change from baseline in Stroke Impact Scale Hand Domain (patient-reported hand function)

  change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed at 90 Day FU visit )

• Change from baseline in Stroke Impact Scale 16 (patient-reported physical functional limitation)

  change from baseline (4-21 days post stroke) to 90 days post stroke (will be assessed on 90 Day FU visit )

Other Outcomes (9)

• Serious procedure or device related adverse events & device deficiencies

  Through study completion, an average of 90 ± 15 days post-stroke (will be assessed on 90 Day FU visit )

• Change in Montreal Cognitive Assessment (global cognitive function)

  will be assessed at 90 Day FU visit

• Change in Patient Health Questionnaire-8 (depression)

  will be assessed on 90 Day FU visit

Study Arms (2)

BQ 2.0 sham stimulation group

SHAM COMPARATOR

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.

Device: BQ 2.0

BQ 2.0 active stimulation group

ACTIVE COMPARATOR

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.

Device: BQ 2.0

Interventions

BQ 2.0 DEVICE

frequency and intensity parameters will be set to zero so that no stimulation is delivered

Also known as: BQ 2.0 sham stimulation group

BQ 2.0 active stimulation group; BQ 2.0 sham stimulation group

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Severe neglect impairment (NIHSS item 11 score = 2) or neglect that is severe enough to interfere with reasonable performance of study procedures. assessments or treatments.
• Implanted active electronic or passive MR-incompatible devices.
• Previous ischemic or hemorrhagic stroke within the 2 weeks before the index stroke.
• Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
• Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or seizure in the last 5 years.
• Significant visual disturbances that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
• Unstable serious illness/condition (eg, active cancer, severe heart failure, active psychiatric condition) or life expectancy of less than 6 12 months.
• A known severe allergic reaction to acrylic-based adhesives.
• Ongoing alcohol abuse and/or illicit drug use.
• Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
• Employee of the Sponsor.
• Prisoner.

Sponsors & Collaborators

• BrainQ Technologies Ltd.: lead

Study Sites (15)

Rancho Research Institute

Downey, California, 90242, United States

Location

Ronald Reagan UCLA Medical Center & California Rehabilitation Institute

Los Angeles, California, 90095, United States

Location

MedStar National Rehabililtaion Hospital,

Washington D.C., District of Columbia, 20010, United States

Location

Brooks Rehabilitation Hospital - University Campus

Jacksonville, Florida, 32216, United States

Location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

KU Medical Center

Kansas City, Kansas, 66160, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08820, United States

Location

Kessler Institute of Rehabilitation

West Orange, New Jersey, 07052, United States

Location

NYP Brooklyn Methodist Hospital Outpatient Rehabilitation

Brooklyn, New York, 11215, United States

Location

Atrium Health Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

TIRR Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Saver JL, Duncan PW, Stein J, Cramer SC, Fox EJ, Zorowitz RD, Billinger SA, Eickmeyer SM, Kirshblum SC, Androwis GJ, Edwards J, Savitz SI, Koch S, Shall MB, Black-Schaffer RM, Bonato P, Cuccurullo SJ, Barcikowski J, Cao N, Bornstein NM; EMAGINE 1 Trial Investigators. Electromagnetic Stimulation to Reduce Disability After Ischemic Stroke: The EMAGINE Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2537880. doi: 10.1001/jamanetworkopen.2025.37880.

  PMID: 41105410 DERIVED

• Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023.

  PMID: 37213907 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jeffrey L Saver, MD

  Lead Coordinating PI

  PRINCIPAL INVESTIGATOR

• Pamela W Duncan, PhD

  Lead Coordinating PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blind study, subjects and Investigators will be blinded to the device setting (Active/Sham). The study site team members receiving, storing, dispensing, preparing, and administering the study interventions will be blinded. Subjects' caregivers will also be blinded. There are no differences in the active and sham device appearance. Due to the non-invasive nature of the treatment, as well as the physical characteristic of the EMF, there is no noticeable difference between sessions conducted using an active or a sham device, facilitating full blinding of both subjects and Investigators. An independent unblinded statistician (not the study statistician) will perform the assessments described. Only the unblinded statistician and members of the DSMB will be exposed to the interim report.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subjects will be assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: September 14, 2021
• Study Start: December 4, 2021
• Primary Completion: November 6, 2023
• Study Completion: January 16, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-02

Locations

US (15)