Effectiveness of Music Therapy on Level of Consciousness

NCT ID: NCT04442971

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2026-12-15

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.

Detailed Description

Due to continuous improvements in acute medical care, the number of patients surviving severe brain damage has increased over the past decades. While some patients improve significantly during the first days after the injury, other patients remain in altered states of consciousness (i.e. coma, unresponsive wakefulness syndrome or minimally conscious state). In patients with disorders of consciousness (DOC), the auditory modality is preferably examined because the responsiveness within the motor and visual modality is often difficult to assess or impaired. Music is a special type of auditory stimulation that can be of particular benefit in DOC patients. The positive effects of music are attributed to the restoration of specific brain networks that are necessary for processing sensory inputs, as well as the emotional aspects of music, which can increase arousal and activate the reward system. Previous studies have shown that music, including passive listening to music, is associated with psychological and physical changes in both healthy and clinical populations. For example, listening to preferred music can reduce pain and anxiety and the need for sedation in different patient groups.

Music therapy has a long tradition in neurological rehabilitation. In DOC patients, passive listening to music is used (in contrast to active therapies used in fully conscious patients). Efficacy results are inconsistent, however, since only a few studies have systematically investigated the effects of music therapy. In previous investigations, either the sample size is very small or no control conditions have been used. A study that met both quality criteria was published by Sun & Chen in 2015. The authors compared two groups: while the music group (n = 20) listened to their favorite music for 15 to 30 minutes three times a day for a period of four weeks, the control group received no stimulation. Although the GCS values increased significantly in both groups, the music group showed a significantly stronger improvement in the level of consciousness. Based on this study, the present study wants to compare the effectiveness of passive listening to music with two control conditions (alternative auditory stimulation and no auditory stimulation) in early neurological rehabilitation patients.

It is a prospective, double-blind, controlled and randomized intervention study that is carried out monocentrically. Over a period of 24 months, 66 patients undergoing early neurological and neurosurgical rehabilitation after severe brain damage are included. For the individual patient, the study duration is a maximum of 38 days (preliminary phase: 3-7 days; intervention phase: 28 days; follow-up phase: 1-3 days). Patients are randomly assigned to one of three study arms (1. Musical stimulation; 2. Alternative auditory stimulation, 3. No auditory stimulation). In the preliminary phase (days 1 to 7), a native MRI (without contrast agent) and a CRS-R assessment are performed. In addition, there is a neurophysiological examination in which evoked potentials are recorded. In the subsequent main phase, the intervention takes place: Over a period of 28 days, the study participants wear headphones for 30 minutes a day, through which they are presented with preferred music (experimental arm), an audio book (comparative arm) or silence (control arm). In the main phase, a CRS-R test is carried out weekly to record the current state of consciousness. In the follow-up phase (1 to 3 days), the (native) MRI examination, the CRS-R assessment and the neurophysiological examination are repeated. The primary outcome measure is an improvement of the level of consciousness, measured with the Coma-Recovery-Scale-Revised (CRS-R).

Conditions

Neurologic Disorder; Traumatic Brain Injury; Disorder of Consciousness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Music Stimulation

Patients preferred music is presented via headphones.

Group Type: EXPERIMENTAL

Music Stimulation

Intervention Type: BEHAVIORAL

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

Alternative Auditory Stimulation

An audio book is presented via headphones.

Group Type: ACTIVE_COMPARATOR

Alternative Stimulation

Intervention Type: BEHAVIORAL

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

No Auditory Stimulation

Silence is presented via headphones.

Group Type: SHAM_COMPARATOR

No Auditory Stimulation

Intervention Type: BEHAVIORAL

Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence.

Interventions

Music Stimulation

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

Intervention Type: BEHAVIORAL

Alternative Stimulation

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

Intervention Type: BEHAVIORAL

No Auditory Stimulation

Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BDH-Klinik Hessisch Oldendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens D Rollnik, MD

Role: STUDY_DIRECTOR

BDH-Clinic Hessisch Oldendorf

Melanie Boltzmann, PhD

Role: PRINCIPAL_INVESTIGATOR

BDH-Clinic Hessisch Oldendorf

Locations

BDH-Clinic Hessisch Oldendorf

Hessisch Oldendorf, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Melanie Boltzmann, PhD

Role: CONTACT

m.boltzmann@bdh-klinik-hessisch.oldendorf

0049 5152 781 256

Simone B Schmidt, PhD

Role: CONTACT

si.schmidt@bdh-klinik-hessisch.oldendorf

0049 5152 781 215

Facility Contacts

Melanie Boltzmann, PhD

Role: primary

m.boltzmann@bdh-klinik-hessisch-oldendorf.de

0049 5152 781 256

References

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.

Reference Type: BACKGROUND

PMID: 26640445 (View on PubMed)

Perrin 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.

Reference Type: BACKGROUND

PMID: 26284020 (View on PubMed)

Hole 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.

Reference Type: BACKGROUND

PMID: 26277246 (View on PubMed)

Chlan 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.

Reference Type: BACKGROUND

PMID: 23689789 (View on PubMed)

Sun J, Chen W. Music therapy for coma patients: preliminary results. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1209-18.

Reference Type: BACKGROUND

PMID: 25912580 (View on PubMed)

Other Identifiers

DOC-MT

Identifier Type: -

Identifier Source: org_study_id