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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT02550275
Collaborator
(none)
44
Enrollment
1
Location
3
Arms
26
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: neuropsychological test
  • Radiation: MRI
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Mar 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: presymptomatic patient

patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5

Behavioral: neuropsychological test

Radiation: MRI
Other: symptomatic patient

patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5

Behavioral: neuropsychological test

Radiation: MRI
Other: controls

unaffected patient with Huntington's disease

Behavioral: neuropsychological test

Radiation: MRI

Outcome Measures

Primary Outcome Measures

  1. the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM [3 months after inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Angers Angers France 49000

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

  • Principal Investigator: SCHERER GAGOU, University Hospital, Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT02550275
Other Study ID Numbers:
  • AOI 201409
First Posted:
Sep 15, 2015
Last Update Posted:
Oct 22, 2020
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Huntington Disease

Study Results

No Results Posted as of Oct 22, 2020