Effectiveness of Music Therapy on Level of Consciousness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBDH-Klinik Hessisch Oldendorf
About this trial
It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
early neurological rehabilitation (phase B)
traumatic brain injury
disorder of consciousness (coma, UWS, MCS)
at minimum two weeks after disease onset
Disqualifiers
insufficient cardiorespiratory stability
fractures or severe infratentorial brain injuries leading to impaired auditory evoked potentials
previous brain damage
Known mental disorders (dementia, depression)
Trial design
Design model
Parallel
Treatments tested in this trial
Music Stimulation
BehavioralPatients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music.
Alternative Stimulation
BehavioralPatients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book.
No Auditory Stimulation
BehavioralPatients wear headphones for 30 minutes/day over a period of four weeks and hear silence.
Treatment groups
66 Participants
are divided into 3 treatment groupsGroup A: Music StimulationExperimental treatment 1 intervention
Group B: Alternative Auditory StimulationActive comparator 1 intervention
Group C: No Auditory StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in level of consciousness
Level of consciousness is measured with the Coma-Recovery-Scale-Revised (Range: 0 to 23) before and after treatment.
Time frame
4 weeksSecondary outcomes
1
Change in connectivity within the default mode network
Patients undergo a MRI scan before and after intervention. Each MRI scan has a duration of 30 minutes. Functional and structural sequences are measured. The resting-state scan (important for the assessment of the default mode network) has a duration of eight minutes and is performed without external stimulation.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov