Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT02134561 |
Date of registration:
|
10/04/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
PREHUNT |
Scientific title:
|
|
Date of first enrolment:
|
September 2013 |
Target sample size:
|
24 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02134561 |
Study type:
|
Interventional |
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
France
| | | | | | | |
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Presymptomatic Huntington Disease
|
Intervention(s)
|
Radiation: MRI
|
Other: neurological tests
|
Other: cognitive tests
|
Behavioral: psychological interview
|
Primary Outcome(s)
|
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,]
|
Secondary ID(s)
|
2013-A00088-37
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|