EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Ischemic Stroke Clinical Trial

Official title: The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (the "EMAGINE 2.0" Study)

Status Not yet recruiting

Clinical Trial Summary

This is a multicenter study that will be conducted at approximately 15 centers.

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 BQ 3.0 system is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies. Up to 45 sessions between days 4 and 90 (±15) after the onset of the index stroke, with up to 5 treatments per week. Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program.

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 3.0 system

Clinical Trial Description

The study intervention will be initiated 4-21 days after the index stroke event and will consist of a total of 45 sessions over a period of 9 weeks (5 treatments per week). Each session will last 60 minutes during which 40 net minutes of active or sham study intervention using BQ 3.0 will be administered in conjunction with a home-based exercise program.

Screening phase:

Prospective subjects, who are 3 to 21 days post-stroke, may be offered informed consent to participate in the study at either:

1. a participating inpatient or outpatient center,

2. non-participating inpatient or outpatient center, in accordance with both the participating and the non-participating centers' policy, or

3. home Consented subjects, who are 4 to 21 days post-stroke, will be screened for eligibility to participate in the treatment phase of the study.

Eligible subjects will be randomly assigned, at a 1:1 allocation ratio, to either the active or sham study intervention groups.

Stimulation with BQ 3.0 does not produce any noticeable sound, light, or tactile sensation which could disclose the treatment arm assignment, making this device ideal for testing in a sham-controlled design. During sham treatment sessions, for purposes of maintaining the blind, the device will function as if it is delivering the therapy (i.e., the device will turn on and all indicators will function), but the frequency and intensity parameters, which are not visible to the subject or site study members (and any blinded personnel), will be set to zero so that no stimulation is delivered.

Treatment Phase:

Efforts should be made to initiate the 1st treatment as early as possible within the window of recruitment, and target to complete a first treatment within 6 days from admission to a participating IRF (where applicable). The study intervention will be initiated 4-21 days after the index stroke event and will consist of a total of 45 sessions over a period of 9 weeks (5 treatments per week). Missed sessions may be made up until the primary endpoint follow-up visit, at day 90 (±15) after the onset of the index stroke Each session will last approximately 60 minutes and include 40 minutes of active or sham stimulation. Subjects in both groups will be asked to perform a home- based exercise program for the upper and the lower limb, concurrent with the study intervention. The program will be standardized, pre-defined, home-based, and aligned with standard-of-care1.

The participant and their caregiver will be trained on the use of the device and exercise program. Treatment sessions will be completed by the subject with the assistance of a trained caregiver, as needed. Periodic supervision will be provided by the study team (combined audio and video remote conferencing or audio only, if video is not available). A sponsor's representative will provide in-person or remote technical support to the participant and their caregiver, as well as device training, as needed.

Subjects will undergo a detailed interim outcome assessment on the 45th (±4) day after the onset of the index stroke, and a detailed primary endpoint outcome assessment on the 90th (±15) day after the onset of the index stroke. In addition, a focused, long-term outcome assessment on the 180th (±15) day after the onset of the index stroke will be performed.

Any adverse events and device deficiencies occurring during the period of subject's participation in the trial will be recorded.

Participation in the study will not replace any of the usual care patient should receive. ;

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT06386874
• Study type: Interventional
• Source: BrainQ Technologies Ltd.
• Contact: Assaf Lifshitz
• Phone: 9720544586787
• Email: assaf@brainqtech.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: October 2026