108 Participants Needed

Music Therapy for Parkinson's Disease and Lewy Body Dementia

KM
CJ
Overseen ByCharles J Hill
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Massachusetts, Worcester
Must be taking: Carbidopa/Levodopa
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to test whether a music therapy intervention (MT) prevents hospital-acquired delirium (HaD) in patients with Parkinson's disease (PD) and Dementia with Lewy Bodies (DLB). Delirium is defined as a mental state in which you are confused, disoriented, and not able to think or remember clearly. It can start suddenly and is usually temporary. It is common among patients with PD/DLB during hospitalization.We are conducting a randomized controlled feasibility pilot study of music therapy (MT) in patients with PD/DLB in the inpatient acute hospital setting.We are testing if receiving music therapy lowers the risk of delirium, compared to other interventions. We are also testing if music therapy lowers the need for certain restraints and medications during the hospitalization.Participants admitted to UMass Memorial Medical Center will be invited to participate. Participants will be asked to undergo a music therapy intervention for 30 minutes 3 times per week, and to listen to personalized music playlists for 60 minutes 4 times per week. Participants will be assessed for HaD every 24 hours, and will undergo additional surveys and questionnaires.Researchers will compare the music therapy intervention to two another comparison groups: one group assigned to listen to music on their own, and one group assigned to receive only standard treatments. About one-third of the participants will be assigned to each of the three study groups.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants with carbidopa/levodopa on their medication list are eligible, suggesting you may continue taking these medications.

Is music therapy safe for humans?

Music therapy is generally considered safe and has been used in various clinical settings without known side effects, including for conditions like dementia and Parkinson's disease.12345

How is music therapy different from other treatments for Parkinson's disease and Lewy Body Dementia?

Music therapy is unique because it uses rhythmic auditory cues and musical activities to improve motor and emotional functions, helping patients with Parkinson's disease and Lewy Body Dementia become more sociable and reduce symptoms. Unlike traditional drug treatments, it focuses on engaging patients through music to enhance their quality of life and social interactions.26789

What data supports the effectiveness of the treatment Music Therapy Intervention for Parkinson's Disease and Lewy Body Dementia?

Research shows that music-based movement therapy can improve motor function in Parkinson's disease patients, and music therapy can enhance social and emotional well-being in individuals with dementia. These findings suggest that music therapy may be beneficial for both motor and emotional symptoms in these conditions.2381011

Are You a Good Fit for This Trial?

This trial is for inpatients at UMass Memorial Medical Center with Parkinson's Disease or Dementia with Lewy Bodies. Candidates must be able to hear and enjoy music, not have a history of music-induced seizures, and should not be sedated in intensive care or expected to leave the hospital within 24 hours.

Inclusion Criteria

I am currently an inpatient at UMass Memorial Medical Center University Campus.
I have been diagnosed with Parkinson's Disease or Dementia with Lewy Bodies, or I am taking carbidopa/levodopa.

Exclusion Criteria

Patients who are currently prisoners will not be included
I am not in the ICU on continuous IV sedation.
You are showing signs of confusion or delirium when first checked by the doctor using a special test called the Confusion Assessment Method (CAM).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Within 24 hours of inpatient admission

Treatment

Participants receive music therapy intervention or control interventions during hospitalization

Up to 15 days
Inpatient setting

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after enrollment

What Are the Treatments Tested in This Trial?

Interventions

  • Music Therapy Intervention
  • Non-guided Music Listening
  • Standard of Care
Trial Overview The study tests if music therapy can prevent confusion and memory problems (delirium) in patients hospitalized with Parkinson's or Lewy Body Dementia. Participants will receive either guided music therapy, listen to their own choice of music, or get standard care without added music intervention.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Music TherapyExperimental Treatment1 Intervention
Music therapy intervention will be administered for 30 minutes 3 times per week between Day 0 and Day 15 of inpatient hospitalization. Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of personalized playlists developed by the music therapist with specific purpose and goal.
Group II: Active ControlActive Control1 Intervention
Daily passive music listening will be required for 30 minutes twice a day, at least 4 days per week. This daily listening experience will consist of non-personalized, auto-generated playlists based on popular genres. No interaction with a music therapist will occur.
Group III: Standard of carePlacebo Group1 Intervention
Usual standard of care.

Music Therapy Intervention is already approved in China, United States for the following indications:

🇨🇳
Approved in China as Music Therapy for:
  • Anxiety reduction in pregnant women
  • Pain relief during labor
  • Stress reduction in high-risk pregnancies
🇺🇸
Approved in United States as Music Therapy for:
  • Antepartum-related distress alleviation
  • Improved caregiver-infant bonding
  • Physiological stress reduction in infants post-partum

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Published Research Related to This Trial

Rhythmic auditory stimulation, which uses music or rhythmic cues, has been shown to effectively improve walking function in patients with Parkinson's disease and other neurological disorders, both during therapy sessions and over time.
Melodic intonation therapy can enhance speech abilities in patients with expressive dysphasia and supports rehabilitation for conditions like Parkinson's disease and stroke, highlighting the therapeutic potential of music-based interventions.
[Can music therapy for patients with neurological disorders?].Myskja, A.[2008]
Recent studies show that rhythmic auditory stimulation can significantly improve gait parameters in Parkinson's disease, including reducing gait freezing and potentially lowering the risk of falls.
There is emerging evidence that music therapy, including group dancing and singing, may provide both motor and non-motor benefits for patients with Parkinson's disease and other movement disorders, although more rigorous research is needed to confirm these effects.
Music Therapy and Music-Based Interventions for Movement Disorders.Devlin, K., Alshaikh, JT., Pantelyat, A.[2020]
A randomized clinical trial involving 32 residents with Alzheimer's disease and related dementias showed that a singing-based music therapy intervention significantly improved feelings, positive emotions, and social engagement compared to a non-music condition (verbal discussion).
The positive effects of music therapy were particularly notable in individuals with moderate dementia, suggesting that music interventions can enhance psychosocial well-being in this population and should be tailored to patient characteristics.
Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion.Reschke-Hernández, AE., Gfeller, K., Oleson, J., et al.[2023]

Citations

Can music-based movement therapy improve motor dysfunction in patients with Parkinson's disease? Systematic review and meta-analysis. [2018]
Virtual Group Music Therapy for Apathy in Parkinson's Disease: A Pilot Study. [2023]
[Can music therapy for patients with neurological disorders?]. [2008]
Music Therapy and Music-Based Interventions for Movement Disorders. [2020]
Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion. [2023]
Music and elderly. [2014]
The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. [2020]
A neuroscientific perspective on music therapy. [2022]
Does a Live Performance Impact Synchronization to Musical Rhythm in Cognitively Impaired Elderly? [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Active music therapy in Parkinson's disease: an integrative method for motor and emotional rehabilitation. [2022]
[Music therapy on Parkinson disease]. [2019]
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