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

NCT06414967 | Recruiting

• 1 other identifier: MUSIC-HD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Huntington Disease

Keywords

Music Therapy; Irritability; Impulsivity

Outcome Measures

Primary Outcomes (1)

• Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management

  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 Outcomes (6)

• Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management

  Month [1;3;6]

• Describe evolution of impulsivity

  Month [1;3;6]

• Describe evolution of Anxiety.

  Month [1;3;6]

• Describe evolution of the quality of life

  Month [3;6]

• Compliance with musical sessions

  Month [1;3]

Study Arms (1)

Music Intervention

EXPERIMENTAL

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

Interventions

Music Intervention OTHER

Music therapy carried out with Music Care

Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers / CIC

Poitiers, 86000, France

RECRUITING

MeSH Terms

Conditions

Huntington Disease; Impulsive Behavior

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Isabelle BENATRU, Dr

CONTACT

05 49 44 33 89; isabelle.benatru@chu-poitiers.fr

Claire LAFAY-CHEBASSIER, Dr

CONTACT

05 49 44 38 36; claire.lafay-chebassier@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

FR (1)