Huntington's DiseaseCOSIMHNCT02550275
Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging
A study testing neuropsychological test and MRI in people with Huntington's Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- neuropsychological test and MRI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Mar 2017
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all particpipants
- Patient gave its written consent
- between 20 and 70 years
- School level : at least 7 years
- native language: french
- For presymptomatic patient
Show all 11Show fewer
- Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
- Unified Huntington Disease Rating Scale moteur ≤ 5
- For symptomatic patient
- Huntington's disease diagnosed with abnormal number of CAG repeats: 36 < nucleotide expansion (CAG)
- Unified Huntington Disease Rating Scale moteur > 5
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
- Pregnant or lactating women
- Patient with involuntary movement hampering the realization of MRI
Trial locations and contacts
1 site in 1 country.
About this study
Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.
- Conditions
- Huntington's Disease
- Being tested
- neuropsychological test, MRI
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychological testBehavioural
MRIRadiation
| Study group | Role | What they receive |
|---|---|---|
| presymptomatic patient | Other | patient with Unified Huntington's Disease Rating Scale (UHDRS) < 5 Receives: Behavioral: neuropsychological test; Radiation: MRI |
| symptomatic patient | Other | patient with Unified Huntington's Disease Rating Scale (UHDRS) > 5 Receives: Behavioral: neuropsychological test; Radiation: MRI |
| controls | Other | unaffected patient with Huntington's disease Receives: Behavioral: neuropsychological test; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- SCHERER GAGOU, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550275
- Sponsor's protocol ID
- AOI 201409
- Acronym
- COSIMH
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2015
- 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
- Social Cognition in Huntington's Disease: Cognitive Study and Functional and Morphological Imaging
- ClinicalTrials.gov ID
- NCT02550275
- Acronym / sponsor ID
- COSIMH / AOI 201409
- Conditions
- Huntington's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 Sep 2015 (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.
Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| presymptomatic patient | Other | Behavioral: neuropsychological test, Radiation: MRIpatient with Unified Huntington's Disease Rating Scale (UHDRS) < 5 |
| symptomatic patient | Other | Behavioral: neuropsychological test, Radiation: MRIpatient with Unified Huntington's Disease Rating Scale (UHDRS) > 5 |
| controls | Other | Behavioral: neuropsychological test, Radiation: MRIunaffected patient with Huntington's disease |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For all particpipants
- Patient gave its written consent
- between 20 and 70 years
- School level : at least 7 years
- native language: french
Key exclusion criteria (5 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
- Pregnant or lactating women
- Patient with involuntary movement hampering the realization of MRI
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 |
|---|---|---|
| neuropsychological test | Behavioural | controls, presymptomatic patient, symptomatic patient |
| MRI | Radiation | controls, presymptomatic patient, symptomatic patient |
Primary outcome
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM
Time frame: 3 months after inclusion
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.
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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.
SCHERER GAGOU principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychological test and MRI in people with Huntington's 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 11 inclusion and 5 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?
the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM (time frame: 3 months after inclusion). 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.