Radiologically Isolated Syndrome (RIS)OCRISNCT03636789
Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
A study testing Neurological consultation in people with Radiologically Isolated Syndrome (RIS) and Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial summary
This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Radiologically Isolated Syndrome (RIS), Multiple Sclerosis
- What is being tested?
- Neurological consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 6 sitesFrance
- Study dates
- 26 Oct 2018to 5 Nov 2021
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient must have given his informed consent and signed the consent form.
- The patient must be affiliated or beneficiary of a health insurance plan.
- The patient is at least 18 years old (≥) and under 50 years old (≤).
- Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
- Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.
Who cannot join
- The subject participates in another study.
- The subject is in an exclusion period determined by a previous study.
- The subject is under guardianship, curatorship or safeguard of justice.
- The patient is pregnant or breastfeeding
- The subject refuses to sign the consent.
- It is not possible to give the subject informed information.
- Patient presenting a pathological neurological examination.
- Patient with visual acuity less than 5/10 or with ocular instability
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Neurologique Pierre Wertheimer
Bron
Hôpital Guy de Chauliac
Montpellier
Nice University Hospital
Nice
Nimes University Hospital
Nîmes
Pitié Salpêtrière University Hospital (APHP)
Paris
Toulouse University Hospital
Toulouse
About this study
This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.
- Being tested
- Neurological consultation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological consultationOther
study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system
| Study group | Role | What they receive |
|---|---|---|
| Neurological consultation group | Experimental | Not described Receives: Other: Neurological consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the occurrence of oculomotor disorders
using a video-oculographic recording system
Measured: Day 0
Secondary outcomes (3)
To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder
number
Measured: Day 0
To identify a correlation between oculomotor disorders and MRI abnormalities.
Measured: Day 0
To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start26 Oct 2018
- Primary completion21 Oct 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiologically Isolated Syndrome (RIS)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Castelnovo, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636789
- Sponsor's protocol ID
- NIMAO/2017-01/GC-01
- Acronym
- OCRIS
- Status last verified
- Apr 2022
- First submitted
- 16 Aug 2018
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome
- ClinicalTrials.gov ID
- NCT03636789
- Acronym / sponsor ID
- OCRIS / NIMAO/2017-01/GC-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 26 Oct 2018 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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 aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurological consultation group | Experimental | Other: Neurological consultation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patient must have given his informed consent and signed the consent form.
- The patient must be affiliated or beneficiary of a health insurance plan.
- The patient is at least 18 years old (≥) and under 50 years old (≤).
- Patients with radiologically isolated syndrome according to the criteria of Okuda et al. (2009)
- Diagnosis of a radiologically isolated syndrome confirmed by the national expert center of Nice for less than 3 years.
Key exclusion criteria (8 listed)
- The subject participates in another study.
- The subject is in an exclusion period determined by a previous study.
- The subject is under guardianship, curatorship or safeguard of justice.
- The patient is pregnant or breastfeeding
- The subject refuses to sign the consent.
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 |
|---|---|---|
| Neurological consultationstudy of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system | Other | Neurological consultation group |
Primary outcome
Evaluation of the occurrence of oculomotor disorders
Time frame: Day 0
using a video-oculographic recording system
3 secondary outcomes
To establish the prevalence of each of the different types of oculomotor abnormalities that constitute the oculomotor disorder
Time frame: Day 0
To identify a correlation between oculomotor disorders and MRI abnormalities.
Time frame: Day 0
To identify a correlation between oculomotor disorders and the cognitive impairment test (Symbol Digit Modalities Test)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
Related trials for Radiologically Isolated Syndrome (RIS)
Recruiting
Comparison of Digital Biomarkers in Subjects With Radiologically Isolated Syndrome (RIS) and Multiple Sclerosis (MS) Patients With Clinically Normal Neurological Examination
Radiologically Isolated Syndromes; Multiple Sclerosis
RecruitingPhase 2
Bacille Calmette-Guérin (BCG) Vaccine In Radiologically Isolated Syndrome (RIS)
Multiple Sclerosis
RecruitingObservational study
RIS International Cohort
Multiple Sclerosis, Radiologically Isolated Syndrome
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.
Giovanni Castelnovo principal investigator
Nîmes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological consultation in people with Radiologically Isolated Syndrome (RIS) and Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 6 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Evaluation of the occurrence of oculomotor disorders (time frame: Day 0). 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 18 Apr 2022.