Back to resultsFeasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study (VOG-HD)
Primary Purpose
Huntington Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eye-tracking
Sponsored by
About this trial
This is an interventional diagnostic trial for Huntington Disease focused on measuring video oculography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with Huntington's disease
Arm Description
Outcomes
Primary Outcome Measures
saccadic measures with the eye tracker
one measure in the evening and one in the afternoon
Secondary Outcome Measures
Full Information
NCT ID
NCT02563418
First Posted
September 8, 2015
Last Updated
September 29, 2015
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02563418
Brief Title
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
Acronym
VOG-HD
Official Title
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington Disease
Keywords
video oculography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with Huntington's disease
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Eye-tracking
Primary Outcome Measure Information:
Title
saccadic measures with the eye tracker
Description
one measure in the evening and one in the afternoon
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Hue
Phone
33 (0)241353800
Email
sophie.hue@chu-angers.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D Milea
Email
damilea@chu-angers.fr
12. IPD Sharing Statement
Learn more about this trial
Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
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