Parkinsonics: A Controlled Study of Group Singing in Parkinson Disease

NCT02753621 | Completed Phase 2

• 1 other identifier: IRB00065196
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall objective of this study is to observe the effect of group Vocal performance training and performance experience on patients' reported symptoms and quality of life. The effectiveness of PD medications varies significantly in different patients depending on their symptoms. By using music-based interventions to improve symptoms that may be inadequately treated by medications, the investigators hope to improve quality of life in PD patients. "Parkinsonics: A controlled study of group singing for quality of life and voice outcomes in Parkinson disease" (PD) is a controlled crossover behavioral intervention study of once weekly choral classes for patients with idiopathic PD (progressing toward a group performance) and once weekly discussion/support group meetings.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Parkinson Disease Quality of Life Questionnaire (PDQ)-39 scores

  Validated 39-item questionnaire

  Change from baseline scores at 30 weeks

Secondary Outcomes (10)

• Voice-Related Quality of Life

  Change from baseline scores at 30 weeks

• Movement Disorder Society-Unified Parkinson Disease Rating Scale Motor scores

  Change from baseline scores at 30 weeks

• Montreal Cognitive Assessment

  Change from baseline scores at 30 weeks

• Geriatric Depression Scale-15

  Change from baseline scores at 30 weeks

• Lorig Self-efficacy scale

  Change from baseline scores at 30 weeks

Other Outcomes (1)

• Feasibility

  12 weeks

Study Arms (2)

Singing Intervention

EXPERIMENTAL

Twelve weekly group singing classes lasting 60-90 minutes under the direction of a professional choir director and a social worker with a music background.

Behavioral: Group singing

Discussion/Support Group Intervention

ACTIVE COMPARATOR

Twelve weekly 60-90 minute discussion groups led by a facilitator trained in discussion group facilitation; occurring at the same time and in the same location (next door) as experimental intervention (group singing).

Behavioral: Facilitated Discussion Group

Interventions

Group singing BEHAVIORAL

Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.

Singing Intervention

Facilitated Discussion Group BEHAVIORAL

Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.

Discussion/Support Group Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD based on UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria for PD (Hughes et al. 1992).

You may not qualify if:

• Patients unable to consent to the study.
• Patients unable or unwilling to participate in weekly singing classes for 12 weeks, or unwilling to perform in a concert setting.
• Patients with active psychiatric disturbances (agitation, active hallucinations).

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alexander Pantelyat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 31, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share