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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
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Huntington's Disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 10, 2015
Last Updated
October 20, 2020
Sponsor
University Hospital, Angers
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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

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Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging

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