Study of Spinal Cord Stimulation for Treating Disorders of Consciousness A Multicenter, Double-Blind, Randomized Controlled Trial in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the effectiveness and safety of spinal cord stimulation SCS in patients with disorders of consciousness DOC, which include coma, unresponsive wakefulness syndrome, and minimally conscious state following acute brain injuries. Current treatments for DOC are limited, with only a few showing promising results. This multicenter randomized controlled trial aims to provide strong evidence on SCS as a potential therapy to promote arousal in these patients and to help standardize its clinical use. Participants will be randomly assigned to two groups. One group will receive continuous SCS stimulation starting one week after surgery for six months. The other group will receive sham stimulation for the first three months after surgery and then begin SCS stimulation for the following three months. This design allows comparison between early and delayed SCS treatment over a six-month period. During the trial, participants will be monitored through various assessments including consciousness rating scales and motor function evaluations at multiple time points up to six months post-surgery. Researchers will track awakening rates and recovery progress using standardized clinical scales. Safety and effectiveness will be closely observed throughout, with the total study participation lasting up to six months after surgery.

Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation