Music Therapy for Parkinson's Disease and Lewy Body Dementia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Massachusetts, Worcester

Approved in 2 Jurisdictions

Trial Summary

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.

Research Team

Eligibility Criteria

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).

Treatment Details

Interventions

• Music Therapy Intervention (Behavioral Intervention)
• Non-guided Music Listening (Behavioural Intervention)
• Standard of Care (Other)

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.

Participant Groups

Group I: Music Therapy Experimental Treatment 1 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 Control Active Control 1 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 care Placebo Group 1 Intervention

Usual standard of care.

Music Therapy Intervention is already approved in China 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

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Dr. Eric W. Dickson

University of Massachusetts, Worcester

Chief Executive Officer since 2013

MD from UMass Chan Medical School, Master's in Health Care Management from Harvard University

Dr. Andy Karson

University of Massachusetts, Worcester

Chief Medical Officer

MD