Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01207856
Eligibility Criteria:
Inclusion Criteria:
patients
* male or female relapsing remitting or secondary progressive or primary progressive Multiple sclerosis patients according to Polman et al. (2005),
* age 18-55; disease duration \>6 months and ≤15 years,
* right handed,
Patients will be eligible for randomization (cognitive inclusion criterion) if they performed worse than :
* 2 scores \<1 standard deviation (SD) on the scores evaluating information processing speed and attention (IPS-Attention) and 1 score \<1DS on other tests assessing executive functions (EF) and working memory (WM).
or
* if they performed worse than 2 scores \<1 SD on the 5 tests of information processing speed, attention and executive function (SDMT, Stroop and TMT battery GREFEX, and divided attention substests (TAP) and 1 score \<1DS on other tests assessing information processing speed, and executive and attention functions (IPS / FAE) and working memory (WM).
healthy volunteers
* male or female,
* age 18-55 matched for age, gender and education
* Accepting to participate and signing the informed consent
* affiliated to french social security
Exclusion Criteria:
* existing other neurological or psychiatric disorder, visual, oculomotor, auditory and motor impairments precluding ability to perform computerized tasks and the driving simulator tasks,
* prior history of addictive behaviour,
* MS attack in the 2 months preceding the screening,
* corticosteroid pulse therapy within 2 months preceding screening,
* severe cognitive deficits or dementia (MMS\<27), moderate to severe visuospatial incapacity (type IV or V at the Rey figure score \< 28), moderate to severe depression (BDI \>27),
* Participant without driving licence
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01207856
Study Brief:
Protocol Section:
NCT01207856