Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project

NCT ID: NCT05057156

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2024-03-31

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.

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.

Conditions

Cognitive Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

"application supervised by a psychologist via teleconsultations"

patient have app, and teleconsultation with psychologist

Group Type: EXPERIMENTAL

cognitive rehabilitation

Intervention Type: BEHAVIORAL

patients have to use an app with cognitive games

"application in total autonomy"

patients have app, they play when they want

Group Type: PLACEBO_COMPARATOR

cognitive rehabilitation

Intervention Type: BEHAVIORAL

patients have to use an app with cognitive games

"control" group without using the application

patients haven't app

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cognitive rehabilitation

patients have to use an app with cognitive games

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• Validated cognitive inclusion criterion: having a YES response on the cognitive complaint questionnaire :

A.Spontaneous complaint :

Does the patient spontaneously complain of language difficulties?

B.Subjective complaint :

1. Do you search for your words?

2. Do you sometimes feel like you have the word on the tip of your tongue?

3. Do you sometimes have trouble finding the names of people you know well?

4. Do you ever say one word for another?

Exclusion Criteria

• 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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

helene brissart, PhD, HDR

Role: CONTACT

h.brissart@chru-nancy.fr

3383851689

louis maillard, Pr

Role: CONTACT

l.maillard@chru-nancy.fr

383852377

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020-A02482-37

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020PI095

Identifier Type: -

Identifier Source: org_study_id