Huntington DiseaseVOG-HDNCT02563418
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
A study testing Eye-tracking in people with Huntington Disease, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Eye-tracking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Corrected visual acuity >1/10
- Aged over 18 years
- Patient with the mutation that is to say the presence of an abnormal number of trinuclide: CAG> 38 in the first exon of the huntingtin gene.
- Total Functional Capacity Scale (CFT) ≥ 3
Who cannot join
- Patients or trustworthy person who have not given their written consent, informed and signed.
- Patients are not affiliated or who are not entitled to Social Security
- Private patients of liberty by administrative or judicial decision, or patients supervision
- Associated disease with neurological repercussions
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire
Angers, 49000
D Milea, damilea@chu-angers.fr
About this study
The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.
- Conditions
- Huntington Disease
- Being tested
- Eye-tracking
- Keywords
- video oculography
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-trackingDevice
| Study group | Role | What they receive |
|---|---|---|
| Patient with Huntington's disease | Experimental | Not described Receives: Device: Eye-tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
saccadic measures with the eye tracker
one measure in the evening and one in the afternoon
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2017 (estimated)
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 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563418
- Sponsor's protocol ID
- AOI 2013 - 11
- Acronym
- VOG-HD
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
- ClinicalTrials.gov ID
- NCT02563418
- Acronym / sponsor ID
- VOG-HD / AOI 2013 - 11
- Conditions
- Huntington Disease
- Keywords
- video oculography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- May 2014
- Primary completion
- May 2017 (estimated)
- First posted
- 30 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.
The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with Huntington's disease | Experimental | Device: Eye-tracking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Corrected visual acuity >1/10
- Aged over 18 years
- Patient with the mutation that is to say the presence of an abnormal number of trinuclide: CAG> 38 in the first exon of the huntingtin gene.
- Total Functional Capacity Scale (CFT) ≥ 3
Key exclusion criteria (4 listed)
- Patients or trustworthy person who have not given their written consent, informed and signed.
- Patients are not affiliated or who are not entitled to Social Security
- Private patients of liberty by administrative or judicial decision, or patients supervision
- Associated disease with neurological repercussions
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 |
|---|---|---|
| Eye-tracking | Device | Patient with Huntington's disease |
Primary outcome
saccadic measures with the eye tracker
Time frame: 1 day
one measure in the evening and one in the afternoon
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-tracking in people with 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: status not confirmed, as of the sponsor's last update on 30 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie Hue (33 (0)241353800, sophie.hue@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
saccadic measures with the eye tracker (time frame: 1 day). 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 30 Sep 2015.