## Protocol Section
### Identification Module
**NCT ID:** NCT06414967

**Acronym:** MUSIC-HD

**Brief Title:** Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntington's Disease (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)

#### Organization Study ID Info
**ID:** MUSIC-HD
#### Organization
**Class:** OTHER
**Full Name:** Poitiers University Hospital
### Status Module
#### Completion Date
**Date:** 2026-05-20

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-11-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Poitiers University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Huntington Disease

**Keywords:**

- Music Therapy

- Irritability

- Impulsivity

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Music Intervention

**Label:** Music Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Music Intervention

**Description:** Music therapy carried out with Music Care

**Name:** Music Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Describe evolution of irritability in patients with Huntington's disease after 3 months of music therapy combined with conventional management

**Time Frame:** Month 3

#### Secondary Outcomes

**Description:** 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.

**Measure:** Describe evolution of irritability in patients with Huntington's disease with music therapy combined with conventional management

**Time Frame:** Month [1;3;6]

**Description:** 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.

**Measure:** Describe evolution of impulsivity

**Time Frame:** Month [1;3;6]

**Description:** 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

**Measure:** Describe evolution of Anxiety.

**Time Frame:** Month [1;3;6]

**Description:** 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.

**Measure:** Describe evolution of the quality of life

**Time Frame:** Month [3;6]

**Description:** Number of music therapy sessions performed.

**Measure:** Compliance with musical sessions

**Time Frame:** Month [1;3]

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

**Measure:** Describe caregivers feeling about the effect of music intervention on patient's irritability and anxiety

**Time Frame:** Month [3;6]

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** isabelle.benatru@chu-poitiers.fr

**Name:** Isabelle BENATRU, Dr

**Phone:** 05 49 44 33 89

**Phone Ext:** +33

**Role:** CONTACT

**Contact 2:**

**Email:** claire.lafay-chebassier@chu-poitiers.fr

**Name:** Claire LAFAY-CHEBASSIER, Dr

**Phone:** 05 49 44 38 36

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Poitiers

**Contacts:**

***Contact 1:***

- **Name:** Isabelle BENATRU

- **Role:** CONTACT

**Country:** France

**Facility:** CHU Poitiers / CIC

**Status:** RECRUITING

**Zip:** 86000

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003704

- Term: Dementia

- ID: D000002819

- Term: Chorea

- ID: D000020820

- Term: Dyskinesias

- ID: D000009069

- Term: Movement Disorders

- ID: D000020271

- Term: Heredodegenerative Disorders, Nervous System

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000003072

- Term: Cognition Disorders

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9875

- Name: Huntington Disease

- Relevance: HIGH

- As Found: Huntington's Disease

- ID: M10220

- Name: Impulsive Behavior

- Relevance: HIGH

- As Found: Impulsivity

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M6059

- Name: Chorea

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22092

- Name: Heredodegenerative Disorders, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2852

- Name: Huntington Disease

- Relevance: HIGH

- As Found: Huntington's Disease

### Condition Browse Module - Meshes

- ID: D000006816

- Term: Huntington Disease

- ID: D000007175

- Term: Impulsive Behavior

### Misc Info Module

- Version Holder: 2024-05-31
