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

NCT ID: NCT06414967

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Huntington Disease

Keywords

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Music Therapy Irritability Impulsivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Music Intervention

Intervention Type OTHER

Music therapy carried out with Music Care

Interventions

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Music Intervention

Music therapy carried out with Music Care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Poitiers / CIC

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle BENATRU, Dr

Role: CONTACT

Phone: 05 49 44 33 89

Email: [email protected]

Claire LAFAY-CHEBASSIER, Dr

Role: CONTACT

Phone: 05 49 44 38 36

Email: [email protected]

Facility Contacts

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Isabelle BENATRU

Role: primary

Other Identifiers

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MUSIC-HD

Identifier Type: -

Identifier Source: org_study_id