Cognitive ChangePRODDIGENCT05057156
Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
A study testing cognitive rehabilitation in people with Cognitive Change, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- cognitive rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 13Show fewer
- 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?
Who cannot join
- 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.).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
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.
Read the detailed description
- best help patients, Norsys enterprise designed the app with three key principles:
- Co-designed, to encourage the emergence of original solutions about uses from patients and therapists,
- User-friendly, to encourage the patient to exercise regularly and with pleasure (soft, optimistic, pleasant and calm mood),
- 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
- Being tested
- cognitive rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive rehabilitationBehavioural
patients have to use an app with cognitive games
| Study group | Role | What they receive |
|---|---|---|
| "application supervised by a psychologist via teleconsultations" | Experimental | patient have app, and teleconsultation with psychologist Receives: Behavioral: cognitive rehabilitation |
| "application in total autonomy" | Placebo comparator | patients have app, they play when they want Receives: Behavioral: cognitive rehabilitation |
| "control" group without using the application | No intervention | patients haven't app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of weekly connections of epileptic patients in each group.
Evaluate the compliance to the digital application by counting the number of connections
Measured: 5 months
Secondary outcomes (14)
Feeling the frequency of lexical access problems
Interview : Questionnaire language score : 0 to 12 points : 12 = worse outcome
Measured: 0 and 5 months
Self-esteem assessment
Interview : Self-esteem score (Rosenberg scale) 0 to 40 points : 40 = better outcome
Measured: 0 and 5 months
Mood assessment
Depression scale score (Neurological Disorder Depression Inventory for Epilepsy : NDDI-E) : 6 to 24 points : 24 = worse outcome
Measured: 0 and 5 months
Anxiety assessment
Anxiety scale score : (Generalized Anxiety Disorder: GAD-7) : 0 to 21 points : 21 = worse outcome
Measured: 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
Measured: 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
Measured: 0 and 5 months
lexicon access assessment in time
Lexicon access tests (Denomination Orale 80): time in second
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 and 5 months
Naming assessment in time
Number of correctly named words Boston Naming Test: time in second
Measured: 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
Measured: 0 and 5 months
Naming assessment BETL intime
BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) : time in second
Measured: 0 and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentric, transversal and randomized trial.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057156
- Sponsor's protocol ID
- 2020PI095
- Other IDs
- 2020-A02482-37
- Acronym
- PRODDIGE
- Status last verified
- May 2021
- First submitted
- 29 Jun 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project
- ClinicalTrials.gov ID
- NCT05057156
- Acronym / sponsor ID
- PRODDIGE / 2020PI095
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- best help patients, Norsys enterprise designed the app with three key principles:
- Co-designed, to encourage the emergence of original solutions about uses from patients and therapists,
- User-friendly, to encourage the patient to exercise regularly and with pleasure (soft, optimistic, pleasant and calm mood),
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- multicentric, transversal and randomized trial.
| Arm | Type | Receives |
|---|---|---|
| "application supervised by a psychologist via teleconsultations" | Experimental | Behavioral: cognitive rehabilitationpatient have app, and teleconsultation with psychologist |
| "application in total autonomy" | Placebo comparator | Behavioral: cognitive rehabilitationpatients have app, they play when they want |
| "control" group without using the application | No intervention | –patients haven't app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- Person with another neurological condition
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive rehabilitationpatients have to use an app with cognitive games | Behavioural | "application in total autonomy", "application supervised by a psychologist via teleconsultations" |
Primary outcome
Number of weekly connections of epileptic patients in each group.
Time frame: 5 months
Evaluate the compliance to the digital application by counting the number of connections
14 secondary outcomes
Feeling the frequency of lexical access problems
Time frame: 0 and 5 months
Self-esteem assessment
Time frame: 0 and 5 months
Mood assessment
Time frame: 0 and 5 months
Anxiety assessment
Time frame: 0 and 5 months
Information processing speed
Time frame: 0 and 5 months
Lexicon access assessment
Time frame: 0 and 5 months
lexicon access assessment in time
Time frame: 0 and 5 months
Selective and sustained attention assessment
Time frame: 0 and 5 months
Working memory assessment
Time frame: 0 and 5 months
Verbal fluency assessment
Time frame: 0 and 5 months
Naming assessment Boston naming task
Time frame: 0 and 5 months
Naming assessment in time
Time frame: 0 and 5 months
Naming assessment BETL
Time frame: 0 and 5 months
Naming assessment BETL intime
Time frame: 0 and 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive rehabilitation in people with Cognitive Change, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact helene brissart, PhD, HDR (3383851689, h.brissart@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of weekly connections of epileptic patients in each group. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.