Pilot Study of Paired Vagus Nerve Stimulation and Robotic Mobilization for Patients With Prolonged Disorders of Consciousness

What this Trial Is About

This research investigates the combined use of transauricular vagus nerve stimulation taVNS and robotic tilt table mobilization RTTM to enhance functional recovery in patients with prolonged disorders of consciousness pDOC following severe acquired brain injury. These conditions typically persist longer than one year after traumatic brain injury or more than three months after non-traumatic brain injury, with few reliable treatment options currently available. The study aims to assess the safety, feasibility, and preliminary outcomes of this combined intervention. Participants will undergo a 12-week rehabilitation program divided into three phases. Initially, a baseline observation phase includes four weeks of standard care without study interventions, followed by a four-week period of mobilization using robotic tilt table physical therapy. This is succeeded by a four-week phase combining the robotic mobilization with simultaneous taVNS. Throughout these phases, assessments using coma recovery and functional scales will be conducted. During the study, participants will be evaluated at baseline, after each phase, and at 3, 6, and 12 months post-intervention using scales such as the Coma Recovery Scale-Revised, Glasgow Coma Scale, and Glasgow Outcome Scale-Extended. Secondary measures include healthcare utilization data like readmission rates and emergency room visits. The study involves careful monitoring of medical status and rehabilitation progress over the entire study period.

Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness