Effectiveness of Music Therapy on Level of Consciousness
Investigation of the Effectiveness of Music Therapy on the Level of Consciousness of Neurological Early Rehabilitation Patients
1 other identifier
interventional
66
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
ExpectedSeptember 19, 2025
September 1, 2025
6 years
June 17, 2020
September 18, 2025
Conditions
Keywords
Outcome Measures
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.
4 weeks
Secondary Outcomes (1)
Change in connectivity within the default mode network
4 weeks
Study Arms (3)
Music Stimulation
EXPERIMENTALPatients preferred music is presented via headphones.
Alternative Auditory Stimulation
ACTIVE COMPARATORAn audio book is presented via headphones.
No Auditory Stimulation
SHAM COMPARATORSilence is presented via headphones.
Interventions
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music.
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book.
Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence.
Eligibility Criteria
You may qualify if:
- early neurological rehabilitation (phase B)
- traumatic brain injury
- disorder of consciousness (coma, UWS, MCS)
- at minimum two weeks after disease onset
- admission to intensive care unit
- written consent from the patient's legal representative
You may not qualify if:
- insufficient cardiorespiratory stability
- fractures or severe infratentorial brain injuries leading to impaired auditory evoked potentials
- previous brain damage
- Known mental disorders (dementia, depression)
- hearing loss or deafness in one or two ears
- wounds that do not allow you to wear headphones
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight\>120 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BDH-Clinic Hessisch Oldendorf
Hessisch Oldendorf, 31840, Germany
Related Publications (5)
Kotchoubey B, Pavlov YG, Kleber B. Music in Research and Rehabilitation of Disorders of Consciousness: Psychological and Neurophysiological Foundations. Front Psychol. 2015 Nov 27;6:1763. doi: 10.3389/fpsyg.2015.01763. eCollection 2015.
PMID: 26640445BACKGROUNDPerrin F, Castro M, Tillmann B, Luaute J. Promoting the use of personally relevant stimuli for investigating patients with disorders of consciousness. Front Psychol. 2015 Jul 30;6:1102. doi: 10.3389/fpsyg.2015.01102. eCollection 2015.
PMID: 26284020BACKGROUNDHole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
PMID: 26277246BACKGROUNDChlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
PMID: 23689789BACKGROUNDSun J, Chen W. Music therapy for coma patients: preliminary results. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1209-18.
PMID: 25912580BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jens D Rollnik, MD
BDH-Clinic Hessisch Oldendorf
- PRINCIPAL INVESTIGATOR
Melanie Boltzmann, PhD
BDH-Clinic Hessisch Oldendorf
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 23, 2020
Study Start
June 15, 2020
Primary Completion
June 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Period of availability begins when results are published, at the earliest in Dec 2022
- Access Criteria
- IPD can be obtained from the principal investigator upon reasonable request.
All IPD that underlie results in a publication.