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Decoding Presymptomatic White Matter Changes in Huntington Disease (Win-HD)

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ClinicalTrials.gov Identifier: NCT03193099
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

WIN-HD is a monocentric longitudinal study comparing premanifest Huntingtin (HTT) mutation carriers and non HTT mutation carriers to determine that white-matter atrophy occurs far earlier than clinical onset in HD using Diffusion-weighted Nuclear Magnetic Resonance (N spectroscopy (DWS) and Diffusion Tensor Imaging (DTI).

The investigators will recruit up to 20 premanifest HTT mutation carriers (15 completed) and up to 20 non HTT mutation carriers (15 completed). It is important to have those 2 populations in order to compare our results and determine if there are significant white-matter changes far from the onset of HD. Therefore, non HTT mutation carriers will be age and gender matched to premanifest HTT mutation carriers.

In order to test the hypothesis, the study has 2 visits with a year interval.

This study is based on 4 principal criteria:

  1. Imaging criteria
  2. Clinical and neurological criteria
  3. Psychological criteria
  4. Behavioral criteria

Condition or disease Intervention/treatment Phase
Huntington Disease White Matter Alterations Other: Brain imaging Other: Neurological assessments Behavioral: Psychological assessments Behavioral: Behavioural assessments Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Decoding Presymptomatic White Matter Changes in Huntington Disease
Actual Study Start Date : July 11, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Premanifest HTT mutation carriers Other: Brain imaging
Volume, DWS and DTI
Other: Neurological assessments
UHDRS
Behavioral: Psychological assessments
STAI (Spielberger state and Trait Anxiety Inventory) A and B, BDI-II (Beck Depression Inventory), MINI (Mini-International Neuropsychiatric Interview) and MINI-SEA (mini Social cognitive and Emotional Assessment)
Behavioral: Behavioural assessments
Computerized game
non HTT mutation carriers Other: Brain imaging
Volume, DWS and DTI
Other: Neurological assessments
UHDRS
Behavioral: Psychological assessments
STAI (Spielberger state and Trait Anxiety Inventory) A and B, BDI-II (Beck Depression Inventory), MINI (Mini-International Neuropsychiatric Interview) and MINI-SEA (mini Social cognitive and Emotional Assessment)
Behavioral: Behavioural assessments
Computerized game



Primary Outcome Measures :
  1. Detection by Diffusion-weighted spectroscopy of abnormal white matter changes prior to the onset of Huntington disease comparing HTT mutation carriers and non HTT mutation carriers over one year [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Detection by Diffusion-weighted spectroscopy of abnormal white matter changes over one year as an intersubject evolution [ Time Frame: one year ]
  2. Detection by Diffusion Tensor Imaging of abnormal white matter changes prior to the onset of Huntington disease comparing HTT mutation carriers and non HTT mutation carriers over one year. [ Time Frame: one year ]
  3. Detection by Diffusion Tensor Imaging white matter changes over one year as an intersubject evolution. [ Time Frame: one year ]
  4. Detection of abnormal scores from psychological tests to assess possible early non motor changes and their intersubject evolution over one year. [ Time Frame: one year ]
  5. Detection of choice rates and time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year. [ Time Frame: one year ]
  6. Detection of time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year. [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For presymptomatic individuals:

    • Genetic test available with CAG (Cytosine-Adenine-Guanine) repeat length > 36 in HTT gene
    • UHDRS score <5
    • Burden score <250
  • For controls:

    - Genetic test available with CAG repeat length ≤ 36 in HTT gene

  • Common inclusion criteria for presymptomatic individuals and controls (age-matched and gender-matched with presymptomatic individuals and but without any familial relationship):

    • At least 18 years of age
    • Capacity to consent
    • Signature of the informed consent
    • Covered by social security
    • Ability to undergo MRI scanning

Non-Inclusion Criteria:

  • Under the age of 18 years of age
  • Contra-indications to MRI examination (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, person with an history of seizure, metallic contraceptive device, permanent eyelid make up, claustrophobia,…)
  • Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
  • History of severe head injury
  • History of neurological disorder or presence of neurological disorder
  • Participation in a drug trial or exclusion period of another study
  • Pregnancy or breastfeeding
  • Inability to understand information about the protocol
  • Person deprived of their liberty by judicial or administrative decision
  • Person under legal protection (legal guardianship, tutelage or maintenance of justice)
  • Person without any protection and unable to consent

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): NCT03193099


Contacts
Contact: Elodie PETIT +33 1 57 27 45 31 elodie.petit@icm-institute.org
Contact: Tiffany MONNIER +33 1 57 27 42 22 tiffany.monnier@icm-institute.org

Locations
France
Brain and Spine Institute Recruiting
Paris, France, 750013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
University College, London
Investigators
Principal Investigator: Alexandra DURR, PU-PH Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03193099     History of Changes
Other Study ID Numbers: C16-115
2017-A00589-44 ( Registry Identifier: RCB )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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
Leukoaraiosis
Dementia
Chorea
Dyskinesias
Pathologic Processes