Huntington's DiseasePhase 1NCT00178360
Effects of Music Therapy on Huntington's Disease
A Phase 1 study testing Music Therapy in people with Huntington's Disease, run by University of Rochester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anyone without the preceding characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: The Effects of Music Therapy on Depression, Chorea and Other Symptoms of Huntington's Disease
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.
Read the 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.
- Conditions
- Huntington's Disease
- Being tested
- Music Therapy
- Keywords
- Huntington's Disease, Music Therapy, quality of life
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | 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. Receives: Behavioral: Music Therapy |
| Standard Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD.
Measured: End of Study
Secondary outcomes (1)
To determine if MT improves the mood and motor features of HD while improving quality of life.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OJ Sahler, University of Rochester
- Investigators
- Frederick J Marshall, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178360
- Sponsor's protocol ID
- 10336
- Status last verified
- Aug 2011
- First submitted
- 12 Sep 2005
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Music Therapy on Depression, Chorea and Other Symptoms of Huntington's Disease
- ClinicalTrials.gov ID
- NCT00178360
- Acronym / sponsor ID
- 10336
- Conditions
- Huntington's Disease
- Keywords
- Huntington's Disease, Music Therapy, quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Behavioral: Music TherapySubject 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. |
| Standard Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Anyone without the preceding characteristics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyDuring 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 | Behavioural | Music Therapy |
Primary outcome
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD.
Time frame: End of Study
1 secondary outcome
To determine if MT improves the mood and motor features of HD while improving quality of life.
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
- Results publicationHyson 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.
- American Music Therapy Association Home PageLink provided by the sponsor.
- Huntington's Disease Society of America Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick J Marshall, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Music Therapy in people with Huntington's Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the feasibility and tolerability of a treatment program of MT for subjects with HD. (time frame: End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.