Status:
COMPLETED
Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Merck Serono International SA
ARSEP foundation
Conditions:
Multiple Sclerosis
Cognitive Rehabilitation
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Despite the need for cognitive rehabilitation, there is a paucity of well-designed research studies to investigate treatment approaches or their effectiveness in MS. Most of published studies suffer f...
Detailed Description
: Multiple Sclerosis (MS) is the most frequent disabling neurological disease in young adults. Over the past two decades, cognitive impairment in MS has received increasing interest. Although for a lo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01207856
Start Date
May 1 2011
End Date
February 1 2016
Last Update
February 9 2016
Active Locations (1)
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1
Service de Neurologie - Pôle des Neurosciences Cliniques, CHU de Bordeaux.
Bordeaux, France, 3300