Investigation of the Effectiveness of Music Therapy on the Level of Consciousness of Neurological Early Rehabilitation Patients

What this Trial Is About

This research aims to evaluate the effectiveness of passive listening to preferred music on the level of consciousness in patients with severe disorders of consciousness (DOC), including coma, unresponsive wakefulness syndrome, or minimally conscious state. The study focuses on patients undergoing early neurological rehabilitation after severe brain damage, where auditory responses are more accessible to measure than motor or visual responses. Music therapy may help restore brain networks and emotional responses, potentially improving consciousness levels. Previous studies have shown mixed results, so this study compares music therapy with other auditory stimulations and no stimulation. Participants are randomly assigned to one of three groups: listening to preferred music, an audio book, or silence through headphones for 30 minutes daily over 28 days. Before this intervention, a preliminary phase of 3 to 7 days includes MRI scans, consciousness assessments using the Coma-Recovery-Scale-Revised (CRS-R), and neurophysiological tests. After the intervention phase, a follow-up period of 1 to 3 days repeats these assessments to measure changes. Throughout the study, consciousness levels are evaluated weekly using the CRS-R to track progress. The main outcome is improvement in consciousness after 4 weeks, with additional brain connectivity changes measured via MRI. Patients are monitored closely with brain scans, neurophysiological exams, and clinical assessments during their maximum 38-day participation. This controlled, double-blind study is conducted at one center and sponsored by BDH-Klinik Hessisch Oldendorf.

Effectiveness of Music Therapy on Level of Consciousness