Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD) (MUSIC-HD)

May 16, 2024 updated by: Poitiers University Hospital

Pilot Study Evaluating the Benefits of Music Therapy Combined With Conventional Treatment on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)

The study is an open-label clinical trial evaluating whether music therapy combined with conventional management reduces irritability and impulsivity in 15 patients with early-stage Huntington's disease. This pilot study aims to show the interest of alternative non-pharmacological measures such as a digital music therapy tool, adapted to an audience of Huntington's patients, to help manage the psychobehavioral symptoms frequently observed in this affection, and to avoid breakdowns due to caregiver exhaustion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers and will receive music therapy for 3 months.

After the start of the musical intervention, 3 visits (at 1 month, 3 months and 6 months) will be performed by practitioners, nurses and neuropsychologist at the CIC. Participants will answer questionnaires : irritability (BITe and PBA-s sub-score), impulsivity (UPPS-P and Delay discounting task), anxiety (STAI-Y and HAM-A), and quality of life: H-QoL-I. Caregivers will be asked to rate the patient's irritability and anxiety using a Lickert scale from 0 to 10, and the patient's impulsivity with the ISDC.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Poitiers, France, 86000
        • Recruiting
        • CHU Poitiers / CIC
        • Contact:
          • Isabelle BENATRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >= 18 years
  • Huntington disease genetically confirmed by the presence of at least 35 repeats of the CAG triplet in exon 1 of the HTT gene
  • UHDRS (Unified Huntington's disease Rating Scale) score <= 5 with a diagnostic confidence score =4
  • Absence of significant cognitive impairment MoCA >=24
  • Stable drug therapy in the 28 days prior inclusion and during the study
  • Without legal tutors or subordination
  • Affiliated to a health insurance system as required by the French law on biomedical research
  • Written informed consent for participation in the study

Exclusion Criteria:

  • Inability to give free and informed consent for study participation
  • Significant hearing impairment
  • Participating to another study the day of enrollement
  • Persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Intervention
The rythm of the music sessions will be 1 per week in the first month and every 15 days in the second and third month.
Other: Music Intervention
Music therapy carried out with Music Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management
Time Frame: Month 3
Score of The brief Irritability Test (BITe). It consists of 5 questions, each rated on likert-type scale with 6 responses options, each question scores to 1 to 6. Lower score means a better outcome.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management
Time Frame: Month [1;3;6]

Score of The brief Irritability Test (BITe). It consists of 5 questions, each rated on likert-type scale with 1-6 responses options. Lower score means a better outcome.

Score of Problem Behavior Assessment-short version (PBA-s). It consist of 4 questions, each rated on likert-type scale with 5 responses options, each question scores to 0 to 4. Lower score means a better outcome.
Month [1;3;6]
Describe evolution of impulsivity
Time Frame: Month [1;3;6]

UPPS (Impulsive Behavior Scale). It consists of 20 questions, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome.

Delay discounting task. ISDC (Inventary of Comportement Dyexecutif Syndrom). It consists of 8 questions, each rated on likert-type scale with 3-5 response options. Lower scores means a better outcome.
Month [1;3;6]
Describe evolution of Anxiety.
Time Frame: Month [1;3;6]

STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety.

HAM-A (Hamilton Anxiety Rating Scale) score. It consist of 14 item-scale, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome
Month [1;3;6]
Describe evolution of the quality of life
Time Frame: Month [3;6]
H-QoL-I (Huntington Qualty of Life Instrument), It consist of 11 items scale, each rated on likert-type scale with 5 response options.Lower scores mean a better outcome.
Month [3;6]
Compliance with musical sessions
Time Frame: Month [1;3]
Number of music therapy sessions performed.
Month [1;3]
Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety
Time Frame: Month [3;6]
A lickert scale from 0 to 10. Lower scores mean a better outcome.
Month [3;6]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

May 20, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSIC-HD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Huntington Disease

Clinical Trials on Music Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe