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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Music Intervention
  Music therapy carried out with Music Care

Первичные конечные точки

• Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management [Срок оценки: Month 3]

Вторичные конечные точки (6)

• Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management [Срок оценки: Month [1;3;6]]
• Describe evolution of impulsivity [Срок оценки: Month [1;3;6]]
• Describe evolution of Anxiety. [Срок оценки: Month [1;3;6]]
• Describe evolution of the quality of life [Срок оценки: Month [3;6]]
• Compliance with musical sessions [Срок оценки: Month [1;3]]
• Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety [Срок оценки: Month [3;6]]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU Poitiers / CIC — Poitiers

Идентификаторы

NCT: NCT06414967 · MUSIC-HD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗