The Efficacy of Frequency-tuned Electromagnetic Field Treatment in Supporting Recovery of Subacute Ischemic Stroke Patients A Multicenter Randomized Controlled Trial with the Q Therapeutic System (BQ 3.0)

What this Trial Is About

Researchers are evaluating the Q Therapeutic System (BQ 3.0), a wearable medical device that delivers low-intensity, low-frequency electromagnetic fields to stimulate brain networks. The goal is to reduce disability and support recovery after ischemic stroke in adults aged 22 to 80 years. This multicenter study involves about 20 to 30 centers and compares active treatment to a sham device in a randomized, controlled design. The study has three stages: Stage 1 runs from 4 to 21 days after stroke onset to day 90, where participants receive either active or sham treatment five times per week, completing at least 45 sessions. Each session lasts about 60 minutes, with 40 minutes of stimulation combined with a home-based exercise program. In Stage 2, from day 90 to day 180, all participants who adhered to Stage 1 can continue active treatment up to five times weekly. Stage 3, from day 180 to day 270, involves no treatments but continued follow-up. Participants and caregivers receive training on device use and exercises, with support provided remotely or in person. Researchers assess outcomes at days 45, 90, 180, and 270 after stroke, focusing on changes in neurological disability using the Modified Rankin Scale. Safety is monitored throughout, and participation complements usual care without replacing it.

EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment