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

Huntington Disease Clinical Trial

— MUSIC-HD  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414967
• Other study ID #: MUSIC-HD
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: May 20, 2026

Study information

• Verified date: May 2024
• Source: Poitiers University Hospital
• Contact: Isabelle BENATRU, Dr
• Phone: 05 49 44 33 89
• Email: isabelle.benatru[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 20, 2026
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Huntington Disease
• Impulsive Behavior

Intervention

Other:
• Music Intervention
Music therapy carried out with Music Care

Locations

Country	Name	City	State
France	CHU Poitiers / CIC	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Describe evolution of irritability in patients with Huntington's disease with 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 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.	Month [1;3;6]
Secondary	Describe evolution of impulsivity	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.	Month [1;3;6]
Secondary	Describe evolution of Anxiety.	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	Month [1;3;6]
Secondary	Describe evolution of the quality of life	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.	Month [3;6]
Secondary	Compliance with musical sessions	Number of music therapy sessions performed.	Month [1;3]
Secondary	Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety	A lickert scale from 0 to 10. Lower scores mean a better outcome.	Month [3;6]