Decoding Presymptomatic White Matter Changes in Huntington Disease
NCT ID: NCT03193099
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-07-11
2019-12-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Premanifest HTT mutation carriers
Brain imaging
Volume, DWS and DTI
Neurological assessments
UHDRS
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
non HTT mutation carriers
Brain imaging
Volume, DWS and DTI
Neurological assessments
UHDRS
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
Interventions
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Brain imaging
Volume, DWS and DTI
Neurological assessments
UHDRS
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
Eligibility Criteria
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Inclusion Criteria
* 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
* At least 18 years of age
* Capacity to consent
* Signature of the informed consent
* Covered by social security
* Ability to undergo MRI scanning
* 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
18 Years
ALL
Yes
Sponsors
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University College, London
OTHER
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Alexandra DURR, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Institut National de la Santé Et de la Recherche Médicale, France
Locations
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Brain and Spine Institute
Paris, , France
Countries
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Other Identifiers
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2017-A00589-44
Identifier Type: REGISTRY
Identifier Source: secondary_id
C16-115
Identifier Type: -
Identifier Source: org_study_id
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