Due to continuous improvements in acute medical care, the number of patients surviving
severe brain damage has increased over the past decades. While some patients improve
significantly during the first days after the injury, other patients remain in altered
states of consciousness (i.e. coma, unresponsive wakefulness syndrome or minimally
conscious state). In patients with disorders of consciousness (DOC), the auditory
modality is preferably examined because the responsiveness within the motor and visual
modality is often difficult to assess or impaired. Music is a special type of auditory
stimulation that can be of particular benefit in DOC patients. The positive effects of
music are attributed to the restoration of specific brain networks that are necessary for
processing sensory inputs, as well as the emotional aspects of music, which can increase
arousal and activate the reward system. Previous studies have shown that music, including
passive listening to music, is associated with psychological and physical changes in both
healthy and clinical populations. For example, listening to preferred music can reduce
pain and anxiety and the need for sedation in different patient groups.
Music therapy has a long tradition in neurological rehabilitation. In DOC patients,
passive listening to music is used (in contrast to active therapies used in fully
conscious patients). Efficacy results are inconsistent, however, since only a few studies
have systematically investigated the effects of music therapy. In previous
investigations, either the sample size is very small or no control conditions have been
used. A study that met both quality criteria was published by Sun & Chen in 2015. The
authors compared two groups: while the music group (n = 20) listened to their favorite
music for 15 to 30 minutes three times a day for a period of four weeks, the control
group received no stimulation. Although the GCS values increased significantly in both
groups, the music group showed a significantly stronger improvement in the level of
consciousness. Based on this study, the present study wants to compare the effectiveness
of passive listening to music with two control conditions (alternative auditory
stimulation and no auditory stimulation) in early neurological rehabilitation patients.
It is a prospective, double-blind, controlled and randomized intervention study that is
carried out monocentrically. Over a period of 24 months, 66 patients undergoing early
neurological and neurosurgical rehabilitation after severe brain damage are included. For
the individual patient, the study duration is a maximum of 38 days (preliminary phase:
3-7 days; intervention phase: 28 days; follow-up phase: 1-3 days). Patients are randomly
assigned to one of three study arms (1. Musical stimulation; 2. Alternative auditory
stimulation, 3. No auditory stimulation). In the preliminary phase (days 1 to 7), a
native MRI (without contrast agent) and a CRS-R assessment are performed. In addition,
there is a neurophysiological examination in which evoked potentials are recorded. In the
subsequent main phase, the intervention takes place: Over a period of 28 days, the study
participants wear headphones for 30 minutes a day, through which they are presented with
preferred music (experimental arm), an audio book (comparative arm) or silence (control
arm). In the main phase, a CRS-R test is carried out weekly to record the current state
of consciousness. In the follow-up phase (1 to 3 days), the (native) MRI examination, the
CRS-R assessment and the neurophysiological examination are repeated. The primary outcome
measure is an improvement of the level of consciousness, measured with the
Coma-Recovery-Scale-Revised (CRS-R).