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Completed

NCT Number: NCT03193099

Decoding Presymptomatic White Matter Changes in Huntington Disease

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

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Leukoaraiosis Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms White Matter Alterations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain and Spine Institute

Paris, 750013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Imaging

Other

Volume, DWS and DTI

Neurological assessments

Other

UHDRS

Psychological assessments

Behavioral

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

Behavioral

Computerized game

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • University College, London

Registry information

Acronym: Win-HD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2017
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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