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Effects of Music Therapy on Huntington's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00178360
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):
OJ Sahler, University of Rochester

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date August 22, 2011
Study Start Date  ICMJE July 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD. [ Time Frame: End of Study ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
To determine if MT improves the mood and motor features of HD while improving quality of life. [ Time Frame: End of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
To determine if MT improves the mood and motor features of HD while improving quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Music Therapy on Huntington's Disease
Official Title  ICMJE The Effects of Music Therapy on Depression, Chorea and Other Symptoms of Huntington's Disease
Brief Summary The purpose of this study is primarily to assess the ability of a music therapy program to improve holistically the psychological, somatic, and social symptoms of patients with Huntington 's disease (HD). We hope to demonstrate the benefits of applying music therapy interventions to the management methods of HD, thus paving the way for the development of an effective music therapy program for individuals with HD.
Detailed Description

ABSTRACT

Background: Recent studies show that music therapy helps improve the symptomatic manifestations of Parkinson's Disease. Few studies have looked at music therapy as a treatment for the psychiatric, cognitive and motor symptoms of patients with Huntington's disease (HD).

Objective: To examine the feasibility and tolerability of a treatment program of music therapy for patients with Huntington's disease. Also, to determine if music therapy improves the mood and motor features of HD while improving quality of life.

Methods: Subjects with HD were recruited to participate in a six-week study that included one individual, half-hour music therapy session and one hour-long group session per week. The music therapy protocols were adapted from the Colorado State University's Neurological Music Therapy program and were targeted to HD symptoms including balance and posture, fine motor skills, memory and attention, vocalizations, and mood. In particular the protocols included Rhythmic Auditory Stimulation (RAS), Pattern Sensory Enhancement (PSE), and Therapeutic Instrumental Music Playing (TIMP). Primary outcome of tolerability was to be assessed by the subjects' adherence to the therapeutic protocol, attendance, and the results of an exit survey inquiring about their feelings toward the use of music therapy in HD. A secondary outcome of the study was the change in the Unified Huntington's Disease Rating Scale (UHDRS) score between baseline and study completion.

Results: Five subjects were recruited for study participation (one female and four males). Music therapy was found to be a tolerable and feasible treatment for patients with HD (100% adherence and 98% attendance). Exit surveys demonstrated strongly positive feelings towards the music therapy treatment program in four of the five subjects (one survey was completed with contradictory answers by the subject). While there was improvement in UHDRS scores for finger tapping, pronation/supination and the Luria, these changes did not achieve statistical significance with the small sample size in this study.

Conclusions: Music therapy was well tolerated among subjects with HD in this small study. Future studies are now being planned to look at the efficacy of this intervention in a larger population of HD subjects.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Behavioral: Music Therapy

During individual Music Therapy sessions, subjects will participate in a variety of active music-making opportunities, including: playing musical instruments, singing, improvising, learning relaxation techniques, song writing, and/or lyric analysis. The activities for each session will be determined by both subject and therapist, and will be selected based on preference, emotional state, and desired goals for the day.

Group music therapy sessions will focus on improving socialization, depression, and group dynamics. In this setting, the Music Therapist will choose from the following interventions:

  • Group singing
  • Group drumming
  • Music assisted relaxation
  • Group song writing
  • Lyric analysis
  • Improvisation
  • Music with art
Study Arms  ICMJE
  • Experimental: Music Therapy
    Subject will participate in one, individual, half-hour long music therapy session every other week and one hour-long group music therapy session each month, for a period of three months.
    Intervention: Behavioral: Music Therapy
  • No Intervention: Standard Care
    During the Standard Care time period, participants will continue to receive all of the medical care that they would normally receive for the treatment of Huntington's Disease, without the addition of music therapy services.
Publications * Hyson C, Oliva R, LaDonna KA, Akwaa F, Richards J, Sahler OJ. "A Pilot Study of Music Therapy in Huntington' Disease". Journal of Neurology, Neurosurgery & Psychiatry 2005; 76:A29, Abstract P010.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2010)
11
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
25
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of HD
  • Over the age of 18
  • Patients must be ambulatory, use of a walker or human support is acceptable
  • Patients must be able to communicate their thoughts and feelings

Exclusion Criteria:

  • Anyone without the preceding characteristics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00178360
Other Study ID Numbers  ICMJE 10336
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OJ Sahler, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederick J Marshall, MD University of Rochester
PRS Account University of Rochester
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP