Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414967
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-10
Brief Title:
Study to Evaluate Music Therapy on Irritability and Impulsivity in Patients With Huntingtons Disease MUSIC-HD
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Pilot Study Evaluating the Benefits of Music Therapy Combined With Conventional Treatment on Irritability and Impulsivity in Patients With Huntingtons Disease MUSIC-HD
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSIC-HD
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 Huntingtons 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 Huntingtons 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 patients irritability and anxiety using a Lickert scale from 0 to 10 and the patients impulsivity with the ISDC
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 patients irritability and anxiety using a Lickert scale from 0 to 10 and the patients impulsivity with the ISDC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None