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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00498199
Other study ID # 2006.432
Secondary ID
Status Terminated
Phase N/A
First received July 6, 2007
Last updated September 29, 2010
Start date April 2007

Study information

Verified date July 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
visual tests


Locations

Country Name City State
France Caroline Tilikete Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

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