Effectiveness of Theta-Burst Patterned Temporal Interference Stimulation for Improving Awareness in Patients With Disorders of Consciousness A Multicenter Randomized Double-Blind Controlled Trial

What this Trial Is About

Researchers are evaluating a new brain stimulation method called theta-burst patterned temporal interference stimulation (tTIs) to improve awareness in people with disorders of consciousness (DoC), including vegetative state and minimally conscious state. The study aims to find out if tTIs increases signs of awareness, enhances brain connectivity, and is safe and tolerable. This randomized, double-blind trial compares active tTIs to a sham stimulation that mimics the sensation without delivering real current. Participants are randomly assigned to receive either active tTIs or sham stimulation targeting a deep brain area called the centromedian-parafascicular nuclei complex. The active group receives 30-minute sessions twice daily for 5 days (10 sessions total) with a current of 2 mA per channel. The sham group receives the same session schedule but with no real current after a brief ramp-up. Precise targeting uses individualized MRI navigation. Before and after treatment, participants undergo brain activity tests including EEG and physical exams to assess awareness using the Coma Recovery Scale-Revised (CRS-R). Researchers also monitor brain responses with advanced EEG techniques. Safety and tolerability are tracked during treatment, and participants are followed up by phone at 1, 3, and 6 months to observe long-term changes. The main outcome is the change in CRS-R score within 24 hours after the 5-day treatment course.

Effectiveness of tTIs for Improving Consciousness in Patients With DoC