Effects of Music Therapy on Huntington's Disease
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | August 19, 2011 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD. [ Time Frame: End of Study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD. | ||||
| Change History | Complete list of historical versions of study NCT00178360 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To determine if MT improves the mood and motor features of HD while improving quality of life. [ Time Frame: End of study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
To determine if MT improves the mood and motor features of HD while improving quality of life. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label |
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| 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:
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| Study Arm (s) |
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| Publications * | Wigmore JG. Re: C.C. Fessler, F.A. Tulleners, D.G. Howitt, and J.R. Richards, Determination of mouth alcohol using the Dräger Evidential Portable Alcohol System, Science and Justice 48 (2008) 16-23. Sci Justice. 2008 Sep;48(3):160. No abstract available. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 11 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00178360 | ||||
| Other Study ID Numbers ICMJE | 10336 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | OJ Sahler, University of Rochester | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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