NCT04442971 Effectiveness of Music Therapy on Level of Consciousness
| NCT ID | NCT04442971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BDH-Klinik Hessisch Oldendorf |
| Condition | Neurologic Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2020-06-15 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2020-06-15 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jens D Rollnik, MD
STUDY DIRECTOR
BDH-Clinic Hessisch Oldendorf
Frequently Asked Questions
Who can join the NCT04442971 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Neurologic Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04442971 currently recruiting?
Yes, NCT04442971 is actively recruiting participants. Contact the research team at m.boltzmann@bdh-klinik-hessisch.oldendorf for enrollment information.
Where is the NCT04442971 trial being conducted?
This trial is being conducted at Hessisch Oldendorf, Germany.
Who is sponsoring the NCT04442971 clinical trial?
NCT04442971 is sponsored by BDH-Klinik Hessisch Oldendorf. The principal investigator is Jens D Rollnik, MD at BDH-Clinic Hessisch Oldendorf. The trial plans to enroll 66 participants.