Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT05057156
Status:
UNKNOWN
Last Update Posted:
2021-09-27
First Post:
2021-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
Sponsor:
Central Hospital, Nancy, France
Organization:
Study Overview
Official Title:
Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRODDIGE
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A02482-37 | REGISTRY | ID RCB | View |