Music Therapy in Parkinson's Disease
ConditionParkinson's Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-79
SponsorSiegward -M. Elsas
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parkinson's disease, Hoehn and Yahr stages 1-4
good understanding of the German language
Signed written informed consent
Disqualifiers
Previous music therapy within the last 12 months
Severe hearing impairment
Manifest dementia (MoCA < 20)
Severe physical disability
Trial design
Design model
Single group
Treatments tested in this trial
Music therapy
Other interventionEight 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Music therapy interventionExperimental treatment 1 intervention
Trial outcomes
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.
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.Secondary outcomes
1
Geriatric Depression Scale (GDS-15)
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.
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.2
Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT)
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.
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.3
General Self-Efficacy Scale (SWE)
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.
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.4
Apathy Evaluation Scale (AES)
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.
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.Other outcomes
1
modified Schellong test (orthostatic function)
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.
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).2
Timed up and Go Test (TUG)
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.
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).3
Tremor
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
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.4
Archimedes Spiral
Drawing an Archimedes Spiral measures intensity of tremor; the greater the deviation from a regular spiral, the more severe is the tremor.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Siegward -M. Elsas
Lead sponsor
Klinik Arlesheim
Sponsor institution
Source ClinicalTrials.gov