Background: Epilepsy leads to cognitive impairment in 20-50%. Compared to seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. Memory and language skills are most often impaired. These disorders are well described, multifactorial, but no therapy (drug and/or non-drug) has been validated to date. Recently, cognitive remediation techniques have shown benefits in certain neurological pathologies, such as multiple sclerosis. In adult epilepsy, few previous cognitive remediation studies were performed but suffer significant methodological shortcomings that limit the scope of their results. Studies that have focused on cognitive function have shown promising results for attention and memory. In contrast, in the area of language, no studies have been published. Objective: to evaluate the effectiveness of a digital solution (PRODDIGE\*) on the lexical access capacities in people with epilepsy. Method: Randomized, multicentric, observational study which will compare the use of a digital solution (PRODDIGE) in total autonomy versus the supervised use by a trained neuropsychologist. A neuropsychological assessment will be provided before and after a period of 4 months of use of the digital solution. Material: The medical project aims to offer an application of cognitive remediation to patients who suffer from cognitive impairments and especially language disorders. T The App is like a serious game, it's based on the playfulness of "game" and the seriousness of "medical exercise". During the exercise the patient can ask for clues help and isn't constrained by time in order to succeed "his mission". Conclusion: This will be the first French speaking app specifically dedicated to rehabilitation of language deficits observed in people with epilepsy. The expected benefits are an improvement of the patients' language complaints, the regular use of an adapted digital solution to improve their language difficulties, but also a better understanding of their disorders and an improvement of their self-esteem.
o best help patients, Norsys enterprise designed the app with three key principles: 1. Co-designed, to encourage the emergence of original solutions about uses from patients and therapists, 2. User-friendly, to encourage the patient to exercise regularly and with pleasure (soft, optimistic, pleasant and calm mood), 3. Accessible design, to get an application compatible and adapted to the specifics of these patients (contrast, color, typography, manipulation) According to these principles, the app gives access to 6 mini-games in its first version and will be available on iOS and Android smartphones. These exercises allow patients to work on specific aspects of their pathologies, this is how the exercises are intended to be playful, dynamic (ex. drag'n'drop) and sometimes collaborative.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
patients have to use an app with cognitive games
Number of weekly connections of epileptic patients in each group.
Evaluate the compliance to the digital application by counting the number of connections
Time frame: 5 months
Feeling the frequency of lexical access problems
Interview : Questionnaire language score : 0 to 12 points : 12 = worse outcome
Time frame: 0 and 5 months
Self-esteem assessment
Interview : Self-esteem score (Rosenberg scale) 0 to 40 points : 40 = better outcome
Time frame: 0 and 5 months
Mood assessment
Depression scale score (Neurological Disorder Depression Inventory for Epilepsy : NDDI-E) : 6 to 24 points : 24 = worse outcome
Time frame: 0 and 5 months
Anxiety assessment
Anxiety scale score : (Generalized Anxiety Disorder: GAD-7) : 0 to 21 points : 21 = worse outcome
Time frame: 0 and 5 months
Information processing speed
Computerized Speed Cognitive Test (CSCT): processing speed index: number of correct items in 90 sec. 0 to 110 points : 110 = better outcome
Time frame: 0 and 5 months
Lexicon access assessment
Lexicon access tests (Denomination Orale 80): number of correctly named words (0 to 80 words) : 80 = better outcome
Time frame: 0 and 5 months
lexicon access assessment in time
Lexicon access tests (Denomination Orale 80): time in second
Time frame: 0 and 5 months
Selective and sustained attention assessment
Selective Attention Test: Paced Auditory Serial Audition Test 4 seconds (PASAT): 0 to 60 score : 60 = better outcome
Time frame: 0 and 5 months
Working memory assessment
Backward digit span: number of digits recalled correctly in inverse order: 0 to 9 score: 9 = better outcome
Time frame: 0 and 5 months
Verbal fluency assessment
Verbal Initiation Test: Phonological Fluency: number of words beginning with P given in 2 minutes 0 to 50 words Category fluency test: number of words given in 2 minutes that belong to the category of Animals.0 to 50 words
Time frame: 0 and 5 months
Naming assessment Boston naming task
Number of correctly named words Boston Naming Test: number of correctly named words :0 to 50 points : 50 = better outcome
Time frame: 0 and 5 months
Naming assessment in time
Number of correctly named words Boston Naming Test: time in second
Time frame: 0 and 5 months
Naming assessment BETL
Number of correctly named words (BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) 0 to 54 point : 54 = better outcome
Time frame: 0 and 5 months
Naming assessment BETL intime
BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) : time in second
Time frame: 0 and 5 months
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