Decoding Presymptomatic White Matter Changes in Huntington Disease

Huntington Disease Clinical Trial

— Win-HD  

Official title:

Decoding Presymptomatic White Matter Changes in Huntington Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193099
• Other study ID #: C16-115
• Secondary ID: 2017-A00589-44
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Huntington Disease
• Leukoaraiosis
• White Matter Alterations

Intervention

Other:
• Brain imaging
Volume, DWS and DTI
• 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)
• Behavioural assessments
Computerized game

Locations

Country	Name	City	State
France	Brain and Spine Institute	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	University College, London

Country where clinical trial is conducted

France, 

Outcome

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