Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging (COSIMH)
Primary Purpose
Huntington's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
neuropsychological test
MRI
Sponsored by
About this trial
This is an interventional prevention trial for Huntington's Disease
Eligibility Criteria
Inclusion Criteria:
For all particpipants
- Patient gave its written consent
- between 20 and 70 years
- School level : at least 7 years
- native language: french
For presymptomatic patient
- Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
- Unified Huntington Disease Rating Scale moteur ≤ 5
For symptomatic patient
- Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
- Unified Huntington Disease Rating Scale moteur > 5
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
- Pregnant or lactating women
- Patient with involuntary movement hampering the realization of MRI
Sites / Locations
- CHU Angers
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
presymptomatic patient
symptomatic patient
controls
Arm Description
patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5
patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5
unaffected patient with Huntington's disease
Outcomes
Primary Outcome Measures
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM
Secondary Outcome Measures
Full Information
NCT ID
NCT02550275
First Posted
September 10, 2015
Last Updated
October 20, 2020
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02550275
Brief Title
Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging
Acronym
COSIMH
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
Brief Summary
Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
presymptomatic patient
Arm Type
Other
Arm Description
patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5
Arm Title
symptomatic patient
Arm Type
Other
Arm Description
patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5
Arm Title
controls
Arm Type
Other
Arm Description
unaffected patient with Huntington's disease
Intervention Type
Behavioral
Intervention Name(s)
neuropsychological test
Intervention Type
Radiation
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM
Time Frame
3 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For all particpipants
Patient gave its written consent
between 20 and 70 years
School level : at least 7 years
native language: french
For presymptomatic patient
Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
Unified Huntington Disease Rating Scale moteur ≤ 5
For symptomatic patient
Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
Unified Huntington Disease Rating Scale moteur > 5
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
Pregnant or lactating women
Patient with involuntary movement hampering the realization of MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SCHERER GAGOU
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging
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