Remediation Program Via a "Serious Game" for the Cognitive Functions of Multiple Sclerosis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLille Catholic University
About this trial
The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Relapsing-remitting or progressive multiple sclerosis people defined according to Mc Donald's criteria revised in 2005
Age between ≥ 18 and ≤ 65 years old
Cognitive complaint, with at least one deficient score at the initial neuropsychological examination (<5th percentile of the reference group), one of the scores of which concerns at least one BICAMS test
Have not had a definite relapse for at least 6 weeks
Disqualifiers
Severe cognitive deficit defined by obtaining a deficit score in more than six cognitive processes at the initial neuropsychological assessment.
Neuropsychological care
Inability to receive oral and written information
Inability to use the software (due in particular to motor and / or sensory difficulties),
Trial design
Design model
Parallel
Treatments tested in this trial
Serious game
Diagnostic testThe serious game is accessible via an online platform, on a tablet: 4 20-minutes activities sessions per week must be carried out. The program format in the serious game form makes possible to simultaneously understand a large number of cognitive functions.
Usual HAS care
Diagnostic testThe control group patients will follow the care they need, according to the HAS recommendations. Non-specific cognitive activities notebooks will be provided to them. They will be instructed to perform the 4 20-minutes sessions per week for 4 months.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Remediation program via a "serious game"Experimental treatment 1 intervention
Group B: Classic care (French Haute Autorité de Santé)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the California Verbal Learning Test (CVLT)
The California Verbal Learning Test (CVLT) begins with the examiner reading a list of 16 words. Patients listen to the list and report as many of the items as possible.
Time frame
Change from baseline at 4 and 10 months2
Change in the Brief Visuo-spatial Memory Test (BVMT)
In the Brief Visuospatial/lMemory Test six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. Thus, scores range from 0 to 12.
Time frame
Change from baseline at 4 and 10 months3
Change in the Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Patients are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure: the number correct.
Time frame
Change from baseline at 4 and 10 monthsSecondary outcomes
1
Change in the Auditory-verbal spans in direct or reverse order
This assessment is required to evaluate short time memory and working memory.
Time frame
Change from baseline at 4 and 10 months2
Change in the Stroop Color-Word Test
This assessment is required to evaluate inhibition capacities and sensitivity to interference.
Time frame
Change from baseline at 4 and 10 months3
Change in the Trail Making Test
This assessment is required to evaluate cognitive flexibility abilities.
Time frame
Change from baseline at 4 and 10 months4
Change in the Categorical and phonemic verbal fluency test
This test is required to evaluate the spontaneous flexibility abilities.
Time frame
Change from baseline at 4 and 10 monthsSponsors and contacts
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Source ClinicalTrials.gov