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

October 20, 2020 updated by: University Hospital, Angers
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: presymptomatic patient
patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5
Radiation: MRI
Behavioral: neuropsychological test
Other: symptomatic patient
patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5
Radiation: MRI
Behavioral: neuropsychological test
Other: controls
unaffected patient with Huntington's disease
Radiation: MRI
Behavioral: neuropsychological test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: SCHERER GAGOU, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI 201409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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