EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen ByJoel Stein, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: BrainQ Technologies Ltd.

Stay on your current meds

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: BQ 3.0 Active Stimulation GroupActive Control2 Interventions

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.

Group II: BQ 3.0 Sham Stimulation GroupPlacebo Group2 Interventions

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.