Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project

Cognitive Change Clinical Trial

— PRODDIGE  

Official title:

Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05057156
• Other study ID #: 2020PI095
• Secondary ID: 2020-A02482-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: March 2024

Study information

• Verified date: May 2021
• Source: Central Hospital, Nancy, France
• Contact: helene brissart, PhD, HDR
• Phone: 3383851689
• Email: h.brissart[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cognitive Change
• Epilepsy

Intervention

Behavioral:
• cognitive rehabilitation
patients have to use an app with cognitive games

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feeling the frequency of lexical access problems	Interview : Questionnaire language score : 0 to 12 points : 12 = worse outcome	0 and 5 months
Secondary	Self-esteem assessment	Interview : Self-esteem score (Rosenberg scale) 0 to 40 points : 40 = better outcome	0 and 5 months
Secondary	Mood assessment	Depression scale score (Neurological Disorder Depression Inventory for Epilepsy : NDDI-E) : 6 to 24 points : 24 = worse outcome	0 and 5 months
Secondary	Anxiety assessment	Anxiety scale score : (Generalized Anxiety Disorder: GAD-7) : 0 to 21 points : 21 = worse outcome	0 and 5 months
Secondary	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
Secondary	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
Secondary	lexicon access assessment in time	Lexicon access tests (Denomination Orale 80): time in second	0 and 5 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Naming assessment in time	Number of correctly named words Boston Naming Test: time in second	0 and 5 months
Secondary	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
Secondary	Naming assessment BETL intime	BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) : time in second	0 and 5 months