EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

NCT06386874 | Recruiting DMC FDA Device

• 1 other identifier: BQ7
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 14

Brief 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

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Modified Rankin Scale

  Proportion of subjects achieving an excellent outcome defined as a Modified Rankin Scale (mRS) score of 0-1 at the 90-day post-stroke assessment, reflecting freedom from disability.

  4 to 21 days following an ischemic stroke to 90-day post-stroke

Secondary Outcomes (16)

• Ordinal shift analysis of the mRS (trichotomized at 0-1, 2, 3-6) (Key Secondary Effectiveness Endpoint)

  baseline to the 90-day post-stroke assessment

• Change from Baseline in Modified Rankin Scale (Key Secondary Effectiveness Endpoint)

  baseline (4-21 days post-stroke) to 90 days post-stroke

• Proportion of subjects achieving functional independence (mRS score of 0-2) (Key Secondary Effectiveness Endpoint)

  at the 90-day post-stroke assessment

• Stroke Impact Scale Hand Domain (Lead Secondary Endpoint)

  baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke

• Stroke Impact Scale 16

  baseline (4 to 21 days following an ischemic stroke) to 90-day post-stroke

Other Outcomes (9)

• Serious procedure or device related adverse events & device deficiencies

  Through study completion, an average of 90 ± 15 days post-stroke

• Change in Montreal Cognitive Assessment (global cognitive function)

  at 90-day post-stroke

• Change in Patient Health Questionnaire-8 (depression)

  at 90-day post stroke

Study Arms (2)

BQ 3.0 Sham Stimulation Group

SHAM COMPARATOR

Q Therapeutic System (BQ 3.0) sham stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 3.0 (frequency and intensity parameters will be set to zero so that no stimulation is delivered) including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

Device: Q Therapeutic System (BQ 3.0) - Sham; Device: Q Therapeutic System (BQ 3.0) - Active

BQ 3.0 Active Stimulation Group

ACTIVE COMPARATOR

Q Therapeutic System (BQ 3.0) active stimulation group: Device used: Q Therapeutic System (BQ 3.0) In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

Device: Q Therapeutic System (BQ 3.0) - Sham; Device: Q Therapeutic System (BQ 3.0) - Active

Interventions

Q Therapeutic System (BQ 3.0) - Sham DEVICE

The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. Frequency and intensity parameters will be set to zero so that no stimulation is delivered.

Also known as: BQ 3.0 Sham Stimulation Group

BQ 3.0 Active Stimulation Group; BQ 3.0 Sham Stimulation Group

Q Therapeutic System (BQ 3.0) - Active DEVICE

The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery

Also known as: BQ 3.0 Active Stimulation Group Interventions

BQ 3.0 Active Stimulation Group; BQ 3.0 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.
• SAFE score \>0.
• Age 22 to 80 years of age (inclusive).
• Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
• First ever ischemic stroke, or a recurring ischemic stroke6 occurring at least 3 months after the previous stroke (any stroke), without residual neurological impairment or disability before current stroke.
• Four to 21 days from stroke onset (or last known well).
• Pre-stroke mRS of 0.
• Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
• Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
• Willingness to participate in an exercise activity during study intervention sessions.
• Availability of a relative or other caregiver able to assist in operating an application installed on a mobile device, including a video call, and assist the participant with the exercising program.
• 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.

You may not qualify if:

• Hemineglect impairment (NIHSS item 11, score \>0).
• Implanted active electronic or passive MR-incompatible devices.
• Pre-existing major neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or pre-existing 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 any epileptic seizure in the last 5 years
• Significant visual disturbances, pre-existing or resulting from the index stroke, 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 major psychiatric condition) or life expectancy of less than 12 months.
• A known severe allergic reaction to acrylic-based adhesives.
• Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
• 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 (14)

Rancho Research Institute

Downey, California, 90242, United States

RECRUITING

MedStar National Rehabililtaion Hospital,

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

RECRUITING

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, United States

NOT YET RECRUITING

Emory University School of Medicine

Altanta, Georgia, 30322, United States

NOT YET RECRUITING

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

KUMC- KU Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Hackensack Meridian JFK Johnson Rehabilitation Institute

Edison, New Jersey, 08818, United States

RECRUITING

Kessler Foundation for Rehabilitation

West Orange, New Jersey, 07052, United States

RECRUITING

New York-Presbyterian Brooklyn Methodist Hospital Inpatient Rehabilitation Unit

Brooklyn, New York, 11215, United States

NOT YET RECRUITING

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

RECRUITING

Atrium Health Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

RECRUITING

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

NOT YET RECRUITING

UTHealth Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

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

  Coordinating PI

  STUDY CHAIR

• Joel Stein, MD

  Coordinating PI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assaf Lifshitz

CONTACT

9720544586787; assaf@brainqtech.com

Iren Basanov

CONTACT

972526936695; iren.basanov@brainqtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study, Sponsor, 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 (except the unblinded randomizer). 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 the BQ3. system

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 26, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)