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NCT Number: NCT07734181

Music Therapy in Parkinson's Disease

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).

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Arlesheim AG

Arlesheim, Basel-Landschaft, 4144, Switzerland

Location status: Recruiting

Location contact

Siegward Elsas, Dr. med.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Music Therapy

Other

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.

Primary outcomes

  1. Parkinson Anxiety Scale (PAS)

    Time frame: 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.

    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.

Secondary outcomes

  1. Geriatric Depression Scale (GDS-15)

    Time frame: 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.

    The Geriatric Depression Scale-15 is a 15-item self-report questionnaire assessing depressive symptoms in older adults. Total scores range from 0 to 15, with higher scores indicating greater depression severity.

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

    Time frame: 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.

    The Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) is a 26-item self-report questionnaire assessing autonomic symptoms in patients with Parkinson's disease. Total scores range from 0 to 69, with higher scores indicating greater autonomic dysfunction.

  3. General Self-Efficacy Scale (SWE)

    Time frame: 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.

    The General Self-Efficacy Scale is a 10-item self-report questionnaire assessing optimistic beliefs about coping with difficult demands, problem solving, and adaptation to stressful life events. Total scores range from 10 to 40, with higher scores indicating greater general self-efficacy.

  4. Apathy Evaluation Scale (AES)

    Time frame: 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.

    The Apathy Evaluation Scale (AES) is an 18-item rating scale assessing apathy. Total scores range from 18 to 72, with higher scores indicating greater apathy.

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

    Time frame: 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.

    The Schedule for the Evaluation of Individual Quality of Life (SEIQoL-Q) is a 24-item rating scale assessing quality of life. Items are rated from from 0% to 100%, with higher scores indicating greater quality of life.

  6. Multidimensional Mood Questionnaire (MDBF)

    Time frame: from the beginning of a therapy session to the end of a therapy session, on average over 45 minutes

    The Multidimensional Mood Questionnaire (MDBF) is a 12-item questionnaire used to assess current well-being before and after a music therapy session. Items are assessed on a 5-point Likert Scale form 1-5, with higher scores indicating stronger moods (positive or negative).

  7. Heart Rate Variability (HRV)

    Time frame: 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).

    The degree of heart rate variability correlates with well-being, with lower values indicating an increase in stress and anxiety.

Other outcomes

  1. modified Schellong test (orthostatic function)

    Time frame: 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).

    Continuous measurement of noninvasive blood pressure with the CNAP (Continuous Non-Invasive Arterial Pressure) machine from sitting to standing. Larger drops indicate more severe impairment of orthostatic regulation.

  2. Timed up and Go Test (TUG)

    Time frame: 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).

    The Timed up and Go Test (TUG) measures the time in seconds needed to get up from a chair, walk 3 meters forward and back, and get seated again. The shorter the time needed, the better the ability to walk.

  3. Tremor

    Time frame: 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.

    Tremor is item number 2.10 from the UPDRS-MDS (United Parkinson's Disease Rating Scale - Movement Disorders Society) questionnaire measuring severity of tremor by a 5 point Likert scale from 0 - 4, with higher scores indication more severe tremor

  4. Archimedes Spiral

    Time frame: 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).

    Drawing an Archimedes Spiral measures intensity of tremor; the greater the deviation from a regular spiral, the more severe is the tremor.

  5. Electroencephalography (EEG)

    Time frame: from onset of a therapy session to the end of a therapy session (avg. 45 min.), during the 1st treatment, and during the last treatment (week 8 of the weekly treatment) (average 2 months).

    Power of alpha&theta in cerebral regions and connectivity between cerebral regions will be measured.

  6. Geneva Emotional Music Scale (GEMS-9)

    Time frame: Some music therapy sessions include 4 sections of 5 min. each, which are designed to evoke specific emotions. At the end of each emotional music section, the GEMS-9 Scale measures how strong the experienced emotions were over the preceding 5 minutes.

    The Geneva Emotional Music Scale (GEMS-9) is a 9-item questionnaire which rates the perceived emotions during listening to music, on a 5-point Likert scale from 1-5, with higher scores indicating stronger emotions (positive or negative).

    This scale is designed to measure how effective a piece of music has been to evoke specific emotions.

Study contacts

Contact information is provided by the study sponsor or research team.

Siegward Elsas, Dr. med.

CONTACT

[email protected]

+41 61 705 71 13

Tiffany Huber, Msc.

CONTACT

[email protected]

+41 61 705 71 55

Sponsors and collaborators

Lead sponsor

Siegward -M. Elsas

Other

Registry information

Official study title

Harmonization of Breathing Through Music Therapy and Its Impact on Anxiety, Quality of Life, and Autonomic Dysfunction in Parkinson's Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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