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Recruiting NCT06414967

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

No phase Interventional Huntington Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music Intervention.
Who it may be relevant to
Registry conditions: Huntington Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Other Music Intervention
    Music therapy carried out with Music Care

Primary outcome measures

  • Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management [Time frame: Month 3]
Secondary outcome measures (6)
  • Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management [Time frame: Month [1;3;6]]
  • Describe evolution of impulsivity [Time frame: Month [1;3;6]]
  • Describe evolution of Anxiety. [Time frame: Month [1;3;6]]
  • Describe evolution of the quality of life [Time frame: Month [3;6]]
  • Compliance with musical sessions [Time frame: Month [1;3]]
  • Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety [Time frame: Month [3;6]]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU Poitiers / CIC — Poitiers

Identifiers

NCT: NCT06414967 · MUSIC-HD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗