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Trial record 22 of 32 for:    Recruiting Studies | Huntington Disease

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

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ClinicalTrials.gov Identifier: NCT02550275
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):

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
Huntington's Disease Behavioral: neuropsychological test Radiation: MRI

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2015
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
presymptomatic patient
patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5
Behavioral: neuropsychological test Radiation: MRI
symptomatic patient
patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5
Behavioral: neuropsychological test Radiation: MRI
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 [ Time Frame: 3 months after inclusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550275


Contacts
Contact: Clarisse SCHERER-GAGOU clscherer@chu-angers.fr

Locations
France
CHU Angers Recruiting
Angers, France, 49000
Contact: VERNY    02.41.35.78.56 ext 33    chverny@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: SCHERER GAGOU University Hospital, Angers
More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02550275     History of Changes
Other Study ID Numbers: AOI 201409
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias