Huntington DiseaseWin-HDNCT03193099
Decoding Presymptomatic White Matter Changes in Huntington Disease
A study testing Brain imaging, Neurological assessments and Psychological assessments in people with Huntington Disease and White Matter Alterations, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Huntington Disease, White Matter Alterations
- What is being tested?
- Brain imaging, Neurological assessments and Psychological assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 24Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Conditions
- Huntington Disease, White Matter Alterations
- Being tested
- Brain imaging, Neurological assessments, Psychological assessments, Behavioural assessments
- Medical subject headings
- Huntington Disease, Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain imagingOther
Volume, DWS and DTI
Neurological assessmentsOther
UHDRS
Psychological assessmentsBehavioural
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 assessmentsBehavioural
Computerized game
| Study group | Role | What they receive |
|---|---|---|
| Premanifest HTT mutation carriers | Other | Not described Receives: Other: Brain imaging; Other: Neurological assessments; Behavioral: Psychological assessments; Behavioral: Behavioural assessments |
| non HTT mutation carriers | Other | Not described Receives: Other: Brain imaging; Other: Neurological assessments; Behavioral: Psychological assessments; Behavioral: Behavioural assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (6)
Detection by Diffusion-weighted spectroscopy of abnormal white matter changes over one year as an intersubject evolution
Measured: one year
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.
Measured: one year
Detection by Diffusion Tensor Imaging white matter changes over one year as an intersubject evolution.
Measured: one year
Detection of abnormal scores from psychological tests to assess possible early non motor changes and their intersubject evolution over one year.
Measured: 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.
Measured: one year
Detection of time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start11 Jul 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Alexandra DURR, PU-PH, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193099
- Sponsor's protocol ID
- C16-115
- Other IDs
- 2017-A00589-44
- Acronym
- Win-HD
- Status last verified
- Feb 2020
- First submitted
- 13 Jun 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Presymptomatic White Matter Changes in Huntington Disease
- ClinicalTrials.gov ID
- NCT03193099
- Acronym / sponsor ID
- Win-HD / C16-115
- Conditions
- Huntington Disease, White Matter Alterations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- University College, London
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premanifest HTT mutation carriers | Other | Other: Brain imaging, Other: Neurological assessments, Behavioral: Psychological assessments, Behavioral: Behavioural assessments |
| non HTT mutation carriers | Other | Other: Brain imaging, Other: Neurological assessments, Behavioral: Psychological assessments, Behavioral: Behavioural assessments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- For presymptomatic individuals:
- For controls:
- Common inclusion criteria for presymptomatic individuals and controls (age-matched and gender-matched with presymptomatic individuals and but without any familial relationship):
- 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,…)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain imagingVolume, DWS and DTI | Other | Premanifest HTT mutation carriers, non HTT mutation carriers |
| Neurological assessmentsUHDRS | Other | Premanifest HTT mutation carriers, non HTT mutation carriers |
| Psychological assessmentsSTAI (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 | Premanifest HTT mutation carriers, non HTT mutation carriers |
| Behavioural assessmentsComputerized game | Behavioural | Premanifest HTT mutation carriers, non HTT mutation carriers |
Primary outcome
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
6 secondary outcomes
Detection by Diffusion-weighted spectroscopy of abnormal white matter changes over one year as an intersubject evolution
Time frame: one year
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
Detection by Diffusion Tensor Imaging white matter changes over one year as an intersubject evolution.
Time frame: one year
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
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
Detection of time differences in the behavioral task comparing HTT mutation carriers and non HTT mutation carriers over one year.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra DURR, PU-PH principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain imaging, Neurological assessments and Psychological assessments in people with Huntington Disease and White Matter Alterations, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.