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Clinical Trials in Germany / NCT04442971
Recruiting Not applicable

Effectiveness of Music Therapy on Level of Consciousness

NCT04442971 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2020-06-15
Last updated
2025-09-19

Condition(s) studied

Neurologic DisorderTraumatic Brain InjuryDisorder of Consciousness

Investigational drug(s) / intervention(s)

Music StimulationAlternative StimulationNo Auditory Stimulation

Music Stimulation: Patients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music.

Alternative Stimulation: Patients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book.

No Auditory Stimulation: Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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 * Exclusion of pregnancy Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
BDH-Clinic Hessisch Oldendorf Hessisch Oldendorf Germany Recruiting

More BDH-Klinik Hessisch Oldendorf trials in Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04442971 on ClinicalTrials.gov ↗ ← All trials in Germany