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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02482-37 | Registry Identifier | ID RCB |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "application supervised by a psychologist via teleconsultations" | Experimental | patient have app, and teleconsultation with psychologist |
|
| "application in total autonomy" | Placebo Comparator | patients have app, they play when they want |
|
| "control" group without using the application | No Intervention | patients haven't app |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive rehabilitation | Behavioral | patients have to use an app with cognitive games |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of weekly connections of epileptic patients in each group. | Evaluate the compliance to the digital application by counting the number of connections | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feeling the frequency of lexical access problems | Interview : Questionnaire language score : 0 to 12 points : 12 = worse outcome | 0 and 5 months |
| Self-esteem assessment | Interview : Self-esteem score (Rosenberg scale) 0 to 40 points : 40 = better outcome |
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Inclusion Criteria:
A.Spontaneous complaint :
Does the patient spontaneously complain of language difficulties?
B.Subjective complaint :
Exclusion Criteria:
Patients and normal control :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| helene brissart, PhD, HDR | Contact | 3383851689 | h.brissart@chru-nancy.fr | |
| louis maillard, Pr | Contact | 383852377 | l.maillard@chru-nancy.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2021 | Aug 10, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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multicentric, transversal and randomized trial.
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| 0 and 5 months |
| Mood assessment | Depression scale score (Neurological Disorder Depression Inventory for Epilepsy : NDDI-E) : 6 to 24 points : 24 = worse outcome | 0 and 5 months |
| Anxiety assessment | Anxiety scale score : (Generalized Anxiety Disorder: GAD-7) : 0 to 21 points : 21 = worse outcome | 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 | 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 | 0 and 5 months |
| lexicon access assessment in time | Lexicon access tests (Denomination Orale 80): time in second | 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 | 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 | 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 | 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 | 0 and 5 months |
| Naming assessment in time | Number of correctly named words Boston Naming Test: time in second | 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 | 0 and 5 months |
| Naming assessment BETL intime | BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) : time in second | 0 and 5 months |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |