- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00498199
Visual Impairment, Oscillopsia and Multiple Sclerosis
This study consists of two parts. The first part is a survey to examine vision-specific health-related quality of life in a cohort of patients with multiple sclerosis. We test visual impairment like visual acuity, visual field, colour discrimination, contrast sensitivity, eye movement. The aim of this part is to examine the association between responses to the quality of life scale and objective measures of visual impairment.
The second part is an open controlled study, in which we measure motion detection threshold in MS patients with oscillopsia due to pendular nystagmus and in a group of control subjects. The objective of this part is to determine whether patients with pendular nystagmus develop adaptation to oscillopsia using increased threshold of motion detection. We plan to test the effect of visuo-motor rehabilitation on this threshold in patients with oscillopsia due to pendular nystagmus.
Study Overview
Detailed Description
In the first part, 100 patients with multiple sclerosis are included. A vision-specific health-related quality of life scale and neuro-ophthalmological tests are administered. The duration of intervention is about 3 hours by patient and one year to finish this part.
In the second part, we include about 40 of 100 MS patients who present an oscillopsia due to pendular nystagmus and a group of 20 control subjects. The patients and subject will perform a motion detection task and the vision-specific health-related quality of life, the intervention lasting 1 hour. Then the patients will be randomized in one group treated by rehabilitation (one 30 mn session per week during 3 months) and the other one without treatment. A motion detection task and the vision-specific health-related quality of life scale will be performed at the end of the treatment for both groups.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Lyon, France, 69677
- Caroline Tilikete
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 to 90
- Patients with established multiple sclerosis
- Visual impairment recovering from MS
- Understanding rules task
- Patient can stay set a long time
- Patient's agreement
- Membership to the Social Security
- No relapsing since three months
Exclusion Criteria:
- Brain damage
- Cognitive or behaviour disorder
- Patients with peripheral vestibular, otologic or ophthalmologic pathology antecedent
- Not stabilized disease (other one than MS)
- Patient under guardianship
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caroline Tilikete, MD, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Neurologic Manifestations
- Sensation Disorders
- Multiple Sclerosis
- Sclerosis
- Vision, Low
- Vision Disorders
Other Study ID Numbers
- 2006.432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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