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

P

Poitiers University Hospital

Status

Enrolling

Conditions

Huntington Disease

Treatments

Other: Music Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06414967
MUSIC-HD

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Music Intervention
Experimental group
Description:
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.
Treatment:
Other: Music Intervention

Trial contacts and locations

1

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Central trial contact

Claire LAFAY-CHEBASSIER, Dr; Isabelle BENATRU, Dr

Data sourced from clinicaltrials.gov

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