Study of the Q Therapeutic System BQ 3.0 Electromagnetic Field Treatment to Support Recovery After Subacute Ischemic Stroke

What this Trial Is About

Researchers are evaluating the Q Therapeutic System BQ 3.0, a wearable medical device that delivers very low-intensity, frequency-tuned electromagnetic fields to stimulate brain networks. This study aims to assess whether this treatment can reduce disability and promote recovery in adults who have experienced an ischemic stroke. The study is conducted across multiple centers and compares active treatment with a sham inactive device in a randomized, double-blind design. The study begins 4 to 21 days after the stroke event. In the first stage up to day 90 post-stroke, participants receive either active or sham treatments five times a week, totaling at least 45 sessions. In the second stage day 90 to day 180, all participants who completed stage 1 can continue to receive active treatments up to five times weekly. In the third stage day 180 to day 270, no treatments are given, and participants are monitored until the final visit. Each session lasts about 60 minutes, including 40 minutes of device use combined with a home-based exercise program. Participants will be trained, with caregiver support as needed, to use the device and perform exercises at home. The study team provides periodic remote supervision and technical support. Assessments of recovery and function will occur at multiple points, including days 45, 90, 180, and 270 after the stroke. Researchers will monitor safety by recording any adverse events or device issues. Usual medical care continues alongside the study treatments throughout the participation period.

EMAGINE 2.0 - Electromagnetic Field Ischemic Stroke - Novel Subacute Treatment