Pilot Study Evaluating the Benefits of Music Therapy Combined With Conventional Treatment on Irritability and Impulsivity in Patients With Huntington's Disease (MUSIC-HD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management
时间窗: Month 3
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.
次要结局
- Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management(Month [1;3;6])
- Describe evolution of the quality of life(Month [3;6])
- Describe evolution of impulsivity(Month [1;3;6])
- Describe evolution of Anxiety.(Month [1;3;6])
- Compliance with musical sessions(Month [1;3])
- Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety(Month [3;6])