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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Music Intervention

    Other intervention

    Music therapy carried out with Music Care

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Music InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Month 3

Secondary outcomes

1

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.

Time frame
Month [1;3;6]
2

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.

Time frame
Month [1;3;6]
3

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

Time frame
Month [1;3;6]
4

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.

Time frame
Month [3;6]

Other outcomes

Sponsors and contacts

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