EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment

Conditions

• Ischemic Stroke

Eligibility Criteria

Sex

ALL

Age

22 Years - 80 Years

Healthy Volunteers

Not accepted

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.
• 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

Study Details

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.

Key Dates

Start date

Aug 20, 2024

Status verified

Nov 2024

Primary completion

Jul 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

122 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Sham Comparator: BQ 3.0 Sham Stimulation Group
  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.
• Active Comparator: BQ 3.0 Active Stimulation Group
  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.

Primary Outcome Measure

Change from Baseline in Modified Rankin Scale [ Time Frame: 4 to 21 days following an ischemic stroke to 90-day post-stroke ]

Central Contacts

• Assaf Lifshitz
  9720544586787
  [email protected]
• Iren Basanov
  972526936695
  [email protected]

Locations (14)

Find similar trials in Downey, CA

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