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NCT Number: NCT06414967

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Poitiers / CIC

Poitiers, 86000, France

Location status: Recruiting

Location contact

Isabelle BENATRU

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music intervention

Other

Music therapy carried out with Music Care

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Month [1;3;6]

    Score of The brief Irritability Test (BITe). It consists of 5 questions, each rated on likert-type scale with 1-6 responses options. Lower score means a better outcome.

    Score of Problem Behavior Assessment-short version (PBA-s). It consist of 4 questions, each rated on likert-type scale with 5 responses options, each question scores to 0 to 4. Lower score means a better outcome.

  2. Describe evolution of impulsivity

    Time frame: Month [1;3;6]

    UPPS (Impulsive Behavior Scale). It consists of 20 questions, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome.

    Delay discounting task. ISDC (Inventary of Comportement Dyexecutif Syndrom). It consists of 8 questions, each rated on likert-type scale with 3-5 response options. Lower scores means a better outcome.

  3. Describe evolution of Anxiety.

    Time frame: Month [1;3;6]

    STAI-Y (Form-Y of the State-Trait Anxiety Inventory) score. It consist of 20-item scales providing separate measures of state and trait anxiety (S-Anxiety and T-Anxiety, respectively). On a 4-point Likert scale (1-4), a score equal to 4 indicates the presence of a higher level of anxiety.

    HAM-A (Hamilton Anxiety Rating Scale) score. It consist of 14 item-scale, each rated on likert-type scale with 4 response options. Lower scores mean a better outcome

  4. Describe evolution of the quality of life

    Time frame: Month [3;6]

    H-QoL-I (Huntington Qualty of Life Instrument), It consist of 11 items scale, each rated on likert-type scale with 5 response options.Lower scores mean a better outcome.

  5. Compliance with musical sessions

    Time frame: Month [1;3]

    Number of music therapy sessions performed.

  6. Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety

    Time frame: Month [3;6]

    A lickert scale from 0 to 10. Lower scores mean a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire LAFAY-CHEBASSIER, Dr

CONTACT

[email protected]

05 49 44 38 36 ext. +33

Isabelle BENATRU, Dr

CONTACT

[email protected]

05 49 44 33 89 ext. +33

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: MUSIC-HD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 16, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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