Using music therapy to improve consciousness in patients with brain injuries
Investigation of the Effectiveness of Music Therapy on the Level of Consciousness of Neurological Early Rehabilitation Patients
This study is trying to see if listening to music can help improve awareness in patients with brain injuries who are not fully conscious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | BDH-Klinik Hessisch Oldendorf Academic / other |
| Locations | 1 site (Hessisch Oldendorf) |
| Trial ID | NCT04442971 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of passive music listening on the level of consciousness in patients with disorders of consciousness (DOC) resulting from traumatic brain injuries. It aims to determine whether preferred music can stimulate brain networks associated with sensory processing and emotional responses, potentially leading to improvements in consciousness levels. The study will compare the effects of music stimulation, alternative stimulation, and no auditory stimulation in a controlled setting. Participants will be patients in early neurological rehabilitation who have been in a DOC state for at least two weeks.
Who should consider this trial
Good fit: Ideal candidates include patients with traumatic brain injuries who are in a disorder of consciousness state and have been in this condition for at least two weeks.
Not a fit: Patients with severe cardiorespiratory instability, significant auditory impairments, or other contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the level of consciousness in patients with severe brain injuries, improving their quality of life and rehabilitation outcomes.
How similar studies have performed: While previous studies have shown some positive effects of music therapy in various populations, systematic investigations specifically in DOC patients are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hessisch Oldendorf
- BDH-Clinic Hessisch Oldendorf — Hessisch Oldendorf, Germany (Recruiting)
Study contacts
- Principal investigator: Melanie Boltzmann, PhD — BDH-Clinic Hessisch Oldendorf
- Study coordinator: Melanie Boltzmann, PhD
- Email: m.boltzmann@bdh-klinik-hessisch.oldendorf
- Phone: 0049 5152 781 256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.