Presymptomatic Huntington DiseasePREHUNTNCT02134561
Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
A study testing psychological interview, MRI and cognitive tests in people with Presymptomatic Huntington Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presymptomatic Huntington Disease
- What is being tested?
- psychological interview, MRI and cognitive tests
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Applicants for Huntington's Disease and Presymptomatic Testing
- Aged 18 years and above
- Huntington disease family member
- Subject gave its written consent
Who cannot join
- No national health insurance affiliation
- Being under guardianship
- Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.
- Patient with movement disorder
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Angers
Angers, Pays de la Loire Region, 49933
About this study
The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.
- Conditions
- Presymptomatic Huntington Disease
- Being tested
- psychological interview, MRI, cognitive tests, neurological tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychological interviewBehavioural
MRIRadiation
This MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study
cognitive testsOther
neurological testsOther
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | psychological interview, MRI, neurological tests, cognitive tests Receives: Behavioral: psychological interview; Radiation: MRI; Other: cognitive tests; Other: neurological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years
Measured: 3 months before diagnostic (baseline) ; 2 years after diagnostic,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presymptomatic Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134561
- Sponsor's protocol ID
- 2013-A00088-37
- Acronym
- PREHUNT
- Status last verified
- Feb 2013
- First submitted
- 10 Apr 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Psychological, Cognitive and Social Resources of Applicants for Huntington's Disease and Presymptomatic Genetic Testing
- ClinicalTrials.gov ID
- NCT02134561
- Acronym / sponsor ID
- PREHUNT / 2013-A00088-37
- Conditions
- Presymptomatic Huntington Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2013
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 May 2014 (estimated)
- 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.
The purpose of this study is to assess the psychological, cognitive and social resources of applicants for Huntington's Disease and Presymptomatic Testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Behavioral: psychological interview, Radiation: MRI, Other: cognitive tests, Other: neurological testspsychological interview, MRI, neurological tests, cognitive tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Applicants for Huntington's Disease and Presymptomatic Testing
- Aged 18 years and above
- Huntington disease family member
- Subject gave its written consent
Key exclusion criteria (4 listed)
- No national health insurance affiliation
- Being under guardianship
- Meeting brain MRI exclusion criteria (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body, Renal failure, hypersensitivity of Gadolinium) or refusing MRI.
- Patient with movement disorder
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 |
|---|---|---|
| psychological interview | Behavioural | All subjects |
| MRIThis MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study | Radiation | All subjects |
| cognitive tests | Other | All subjects |
| neurological tests | Other | All subjects |
Primary outcome
Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years
Time frame: 3 months before diagnostic (baseline) ; 2 years after diagnostic,
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 22 Oct 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychological interview, MRI and cognitive tests in people with Presymptomatic Huntington Disease, run by University Hospital, Angers 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 4 inclusion and 4 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 22 Oct 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?
Change from baseline total score of the psychological Unified Huntington's Disease Rating Scale at 2 years (time frame: 3 months before diagnostic (baseline) ; 2 years after diagnostic,). 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 22 Oct 2020.