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

Primary Purpose

Huntington Disease, White Matter Alterations

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain imaging
Neurological assessments
Psychological assessments
Behavioural assessments
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Huntington Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brain and Spine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Premanifest HTT mutation carriers

non HTT mutation carriers

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Detection by Diffusion-weighted spectroscopy of abnormal white matter changes over one year as an intersubject evolution
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.
Detection by Diffusion Tensor Imaging white matter changes over one year as an intersubject evolution.
Detection of abnormal scores from psychological tests to assess possible early non motor changes and their intersubject evolution over one year.
Detection of choice rates and time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year.
Detection of time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year.

Full Information

First Posted
June 13, 2017
Last Updated
February 17, 2020
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT03193099
Brief Title
Decoding Presymptomatic White Matter Changes in Huntington Disease
Acronym
Win-HD
Official Title
Decoding Presymptomatic White Matter Changes in Huntington Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators
University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Imaging criteria Clinical and neurological criteria Psychological criteria Behavioral criteria

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease, White Matter Alterations

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premanifest HTT mutation carriers
Arm Type
Other
Arm Title
non HTT mutation carriers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Brain imaging
Intervention Description
Volume, DWS and DTI
Intervention Type
Other
Intervention Name(s)
Neurological assessments
Intervention Description
UHDRS
Intervention Type
Behavioral
Intervention Name(s)
Psychological assessments
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Behavioural assessments
Intervention Description
Computerized game
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Detection by Diffusion-weighted spectroscopy of abnormal white matter changes over one year as an intersubject evolution
Time Frame
one year
Title
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
Title
Detection by Diffusion Tensor Imaging white matter changes over one year as an intersubject evolution.
Time Frame
one year
Title
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
Title
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
Title
Detection of time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra DURR, PU-PH
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain and Spine Institute
City
Paris
ZIP/Postal Code
750013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Decoding Presymptomatic White Matter Changes in Huntington Disease

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