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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Intervention | Other | Music therapy carried out with Music Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle BENATRU, Dr | Contact | 05 49 44 33 89 | +33 | isabelle.benatru@chu-poitiers.fr |
| Claire LAFAY-CHEBASSIER, Dr | Contact | 05 49 44 38 36 | +33 | claire.lafay-chebassier@chu-poitiers.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Poitiers / CIC | Recruiting | Poitiers | 86000 | France |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Month [1;3;6] |
| 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] |
| 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] |
| 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] |
| Compliance with musical sessions | Number of music therapy sessions performed. | Month [1;3] |
| 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] |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |