Back to resultsAssessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing (PREHUNT)
Primary Purpose
Presymptomatic Huntington Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psychological interview
MRI
cognitive tests
neurological tests
Sponsored by
About this trial
This is an interventional supportive care trial for Presymptomatic Huntington Disease
Eligibility Criteria
Inclusion Criteria:
- Applicants for Huntington's Disease and Presymptomatic Testing
- Aged 18 years and above
- Huntington disease family member
- Subject gave its written consent
Exclusion Criteria:
- No national health insurance affiliation
- Being under guardianship
- Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.
- Patient with movement disorder
Sites / Locations
- University Hospital of Angers
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All subjects
Arm Description
psychological interview, MRI, neurological tests, cognitive tests
Outcomes
Primary Outcome Measures
Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years
Secondary Outcome Measures
Full Information
NCT ID
NCT02134561
First Posted
April 10, 2014
Last Updated
October 20, 2020
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02134561
Brief Title
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
Acronym
PREHUNT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presymptomatic Huntington Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All subjects
Arm Type
Other
Arm Description
psychological interview, MRI, neurological tests, cognitive tests
Intervention Type
Behavioral
Intervention Name(s)
psychological interview
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
This MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study
Intervention Type
Other
Intervention Name(s)
cognitive tests
Intervention Type
Other
Intervention Name(s)
neurological tests
Primary Outcome Measure Information:
Title
Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years
Time Frame
3 months before diagnostic (baseline) ; 2 years after diagnostic,
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Applicants for Huntington's Disease and Presymptomatic Testing
Aged 18 years and above
Huntington disease family member
Subject gave its written consent
Exclusion Criteria:
No national health insurance affiliation
Being under guardianship
Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.
Patient with movement disorder
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49933
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
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