Multiple SclerosisNCT00498199
Visual Impairment, Oscillopsia and Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- visual tests
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to not given
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with established multiple sclerosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- visual tests
- Keywords
- Multiples sclerosis, oscillopsia, eye movements, motion detection, retinal slip, nystagmus
- Medical subject headings
- Multiple Sclerosis, Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual testsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Caroline Tilikete, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498199
- Sponsor's protocol ID
- 2006.432
- Status last verified
- Jul 2007
- First submitted
- 6 Jul 2007
- Last updated
- 30 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Impairment, Oscillopsia and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00498199
- Acronym / sponsor ID
- 2006.432
- Conditions
- Multiple Sclerosis
- Keywords
- Multiples sclerosis, oscillopsia, eye movements, motion detection, retinal slip, nystagmus
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 9 Jul 2007 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with established multiple sclerosis
Key inclusion criteria (8 listed)
- Age 18 to 90
- Patients with established multiple sclerosis
- Visual impairment recovering from MS
- Understanding rules task
- Patient can stay set a long time
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| visual tests | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2010.
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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.
Caroline Tilikete, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hospices Civils de Lyon 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 8 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: stopped early, as of the sponsor's last update on 30 Sep 2010. 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 was stopped early. Results are not available in the source record.
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.
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 2010.