Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
PRODDIGE
2 other identifiers
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2021
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 27, 2021
May 1, 2021
2 years
June 29, 2021
September 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (14)
Feeling the frequency of lexical access problems
0 and 5 months
Self-esteem assessment
0 and 5 months
Mood assessment
0 and 5 months
Anxiety assessment
0 and 5 months
Information processing speed
0 and 5 months
- +9 more secondary outcomes
Study Arms (3)
"application supervised by a psychologist via teleconsultations"
EXPERIMENTALpatient have app, and teleconsultation with psychologist
"application in total autonomy"
PLACEBO COMPARATORpatients have app, they play when they want
"control" group without using the application
NO INTERVENTIONpatients haven't app
Interventions
patients have to use an app with cognitive games
Eligibility Criteria
You may qualify if:
- Person with epilepsy, according to Fisher et al. (2005) criteria: all type of epilepsy could be include (new-onset and drug-resistant)
- Treatment must have been stable for 4 months: have the same molecule
- Person who has received full information about the organization of the research and has not objected to his or her participation and the use of his or her data
- Person aged 18 and over
- Mandatory affiliation to a social security scheme
- A.Spontaneous complaint :
- Does the patient spontaneously complain of language difficulties?
- B.Subjective complaint :
- Do you search for your words?
- Do you sometimes feel like you have the word on the tip of your tongue?
- Do you sometimes have trouble finding the names of people you know well?
- Do you ever say one word for another?
You may not qualify if:
- Person with another neurological condition
- Patients and normal control :
- A person over the age of majority who is subject to a legal protection measure or who is unable to express their consent.
- Person deprived of liberty by a judicial or administrative decision
- A person who regularly uses psychoactive substances (cannabis, alcohol, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Hospital, Nancy, Francelead
- UCB Pharmacollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2021
First Posted
September 27, 2021
Study Start
October 1, 2021
Primary Completion
October 1, 2023
Study Completion
March 1, 2024
Last Updated
September 27, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share