NCT07734181

Brief Summary

This study aims to examine whether individual music therapy - involving the slow, gentle bowing of a string instrument, accompanied by the music therapist's singing and lyre playing - can have a relaxing and calming effect on patients with Parkinson's disease and improve anxiety, quality of life, and autonomic dysfunction such as unstable blood pressure. People with Parkinson's disease often struggle with anxiety, apathy, and depression, which can severely affect their quality of life. These symptoms are usually difficult to treat adequately with medication. They are frequently associated with dysfunction of the autonomic nervous system and a reduced variability of heart rate. Both are common in Parkinson's disease and can provide clues about stress and well-being. A healthy heart does not beat at completely regular intervals; instead, the time between beats constantly changes slightly. This fluctuation is called heart rate variability (HRV). Primary study outcome will be anxiety. Motivation, depression, individual quality of life, and severity of autonomic symptoms are also assessed using validated questionnaires. Physical study measures will be HRV, along with stability of blood pressure, intensity of tremor, ability to walk, and also electroencephalography (EEG) to assess brain activity. A subproject will explore whether listening to emotionally evocative music can specifically influence the brain in patients with Parkinson's disease (as measured by EEG) and autonomic functions (as measured by HRV). The effectiveness of an emotional response will be measured by a questionnaire (the Geneva Emotional Music Scale).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
25mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress7%
Jun 2026Sep 2028

Study Start

First participant enrolled

June 2, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2028

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

2.3 years

First QC Date

July 19, 2026

Last Update Submit

July 29, 2026

Conditions

Keywords

Parkinson's diseaseMusic therapyAnthroposophical music therapyEEGHRVParkinson Anxiety Scale (PAS)

Outcome Measures

Primary Outcomes (1)

  • Parkinson Anxiety Scale (PAS)

    The Parkinson Anxiety Scale (PAS) is a 12-item, Parkinson's disease-specific rating scale that measures anxiety severity across three domains: persistent anxiety, episodic anxiety, and avoidance behavior. Items are rated on a 5-point Likert scale, with higher scores indicating greater anxiety.

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

Secondary Outcomes (7)

  • Geriatric Depression Scale (GDS-15)

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT)

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • General Self-Efficacy Scale (SWE)

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • Apathy Evaluation Scale (AES)

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q)

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • +2 more secondary outcomes

Other Outcomes (6)

  • modified Schellong test (orthostatic function)

    from onset of a therapy session to the end of a therapy session (avg. 45 min.), and 4 weeks before the 1st treatment, immediately before the 1st treatment, after weeks 4 and 8 of the weekly treatment, and 4 weeks after end of therapy (average 4 months).

  • Timed up and Go Test (TUG)

    from onset of a therapy session to the end of a therapy session (avg. 45 min.), and 4 weeks before the 1st treatment, immediately before the 1st treatment, after weeks 4 and 8 of the weekly treatment, and 4 weeks after end of therapy (average 4 months).

  • Tremor

    From four weeks before the first treatment (pre-baseline), immediately before the first treatment (baseline), after weeks 4 and 8 of the weekly treatment, and 4 weeks after the end of therapy (follow-up), through study completion, on average 4 months.

  • +3 more other outcomes

Study Arms (1)

Music therapy intervention

EXPERIMENTAL
Other: Music therapy

Interventions

Eight weekly individual sessions of music therapy for patients with Parkinson's disease. Part 1 - Listening to lyre music (10 minutes) Participants listen to emotionally stimulating lyre music. Part 2 - Active playing of a string instrument (20 minutes) Participants perform slow, calm bowing of a low string instrument, the Tenor Chrotta (with a pitch range comparable to the cello), guided and supported by the singing of the music therapist.

Music therapy intervention

Eligibility Criteria

Age50 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease, Hoehn and Yahr stages 1-4
  • good understanding of the German language
  • Signed written informed consent

You may not qualify if:

  • Previous music therapy within the last 12 months
  • Severe hearing impairment
  • Manifest dementia (MoCA \< 20)
  • Severe physical disability
  • Severe somatic or psychiatric illness
  • Concurrent participation in another clinical trial targeting treatment of Parkinson's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Arlesheim AG

Arlesheim, Basel-Landschaft, 4144, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Siegward Elsas, Dr. med.

    Klinik Arlesheim

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 29, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 2, 2028

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations