Clinical trial NCT06414967: Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Huntington Disease
Keywords: Music Therapy
Irritability
Impulsivity
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Primary outcomes:
measure: Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management
timeFrame: Month 3
Secondary outcomes:
measure: Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management
timeFrame: Month [1;3;6]
measure: Describe evolution of impulsivity
timeFrame: Month [1;3;6]
measure: Describe evolution of Anxiety.
timeFrame: Month [1;3;6]
measure: Describe evolution of the quality of life
timeFrame: Month [3;6]
measure: Compliance with musical sessions
timeFrame: Month [1;3]
measure: Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety
timeFrame: Month [3;6]
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers / CIC
Study officials:
References: