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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-10', 'size': 417786, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-10T07:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicentric, transversal and randomized trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-15', 'studyFirstSubmitDate': '2021-06-29', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of weekly connections of epileptic patients in each group.', 'timeFrame': '5 months', 'description': 'Evaluate the compliance to the digital application by counting the number of connections'}], 'secondaryOutcomes': [{'measure': 'Feeling the frequency of lexical access problems', 'timeFrame': '0 and 5 months', 'description': 'Interview : Questionnaire language score : 0 to 12 points : 12 = worse outcome'}, {'measure': 'Self-esteem assessment', 'timeFrame': '0 and 5 months', 'description': 'Interview : Self-esteem score (Rosenberg scale) 0 to 40 points : 40 = better outcome'}, {'measure': 'Mood assessment', 'timeFrame': '0 and 5 months', 'description': 'Depression scale score (Neurological Disorder Depression Inventory for Epilepsy : NDDI-E) : 6 to 24 points : 24 = worse outcome'}, {'measure': 'Anxiety assessment', 'timeFrame': '0 and 5 months', 'description': 'Anxiety scale score : (Generalized Anxiety Disorder: GAD-7) : 0 to 21 points : 21 = worse outcome'}, {'measure': 'Information processing speed', 'timeFrame': '0 and 5 months', 'description': 'Computerized Speed Cognitive Test (CSCT): processing speed index: number of correct items in 90 sec. 0 to 110 points : 110 = better outcome'}, {'measure': 'Lexicon access assessment', 'timeFrame': '0 and 5 months', 'description': 'Lexicon access tests (Denomination Orale 80): number of correctly named words (0 to 80 words) : 80 = better outcome'}, {'measure': 'lexicon access assessment in time', 'timeFrame': '0 and 5 months', 'description': 'Lexicon access tests (Denomination Orale 80): time in second'}, {'measure': 'Selective and sustained attention assessment', 'timeFrame': '0 and 5 months', 'description': 'Selective Attention Test: Paced Auditory Serial Audition Test 4 seconds (PASAT): 0 to 60 score : 60 = better outcome'}, {'measure': 'Working memory assessment', 'timeFrame': '0 and 5 months', 'description': 'Backward digit span: number of digits recalled correctly in inverse order: 0 to 9 score: 9 = better outcome'}, {'measure': 'Verbal fluency assessment', 'timeFrame': '0 and 5 months', 'description': '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'}, {'measure': 'Naming assessment Boston naming task', 'timeFrame': '0 and 5 months', 'description': 'Number of correctly named words Boston Naming Test: number of correctly named words :0 to 50 points : 50 = better outcome'}, {'measure': 'Naming assessment in time', 'timeFrame': '0 and 5 months', 'description': 'Number of correctly named words Boston Naming Test: time in second'}, {'measure': 'Naming assessment BETL', 'timeFrame': '0 and 5 months', 'description': 'Number of correctly named words (BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) 0 to 54 point : 54 = better outcome'}, {'measure': 'Naming assessment BETL intime', 'timeFrame': '0 and 5 months', 'description': 'BETL task : batterie evaluation troubles lexicaux = assessment of lexical impairment battery) : time in second'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Change']}, 'descriptionModule': {'briefSummary': '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.\n\nObjective: to evaluate the effectiveness of a digital solution (PRODDIGE\\*) on the lexical access capacities in people with epilepsy.\n\nMethod: 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.\n\nMaterial: The medical project aims to offer an application of cognitive remediation to patients who suffer from cognitive impairments and especially language disorders.\n\nT 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".\n\nConclusion: 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.', 'detailedDescription': "o best help patients, Norsys enterprise designed the app with three key principles:\n\n1. Co-designed, to encourage the emergence of original solutions about uses from patients and therapists,\n2. User-friendly, to encourage the patient to exercise regularly and with pleasure (soft, optimistic, pleasant and calm mood),\n3. 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.\n\nThese 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person with epilepsy, according to Fisher et al. (2005) criteria: all type of epilepsy could be include (new-onset and drug-resistant)\n* Treatment must have been stable for 4 months: have the same molecule\n* 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\n* Person aged 18 and over\n* Mandatory affiliation to a social security scheme\n* Validated cognitive inclusion criterion: having a YES response on the cognitive complaint questionnaire :\n\nA.Spontaneous complaint :\n\nDoes the patient spontaneously complain of language difficulties?\n\nB.Subjective complaint :\n\n1. Do you search for your words?\n2. Do you sometimes feel like you have the word on the tip of your tongue?\n3. Do you sometimes have trouble finding the names of people you know well?\n4. Do you ever say one word for another?\n\nExclusion Criteria:\n\n* Person with another neurological condition\n\nPatients and normal control :\n\n* A person over the age of majority who is subject to a legal protection measure or who is unable to express their consent.\n* Person deprived of liberty by a judicial or administrative decision\n* A person who regularly uses psychoactive substances (cannabis, alcohol, etc.).'}, 'identificationModule': {'nctId': 'NCT05057156', 'acronym': 'PRODDIGE', 'briefTitle': 'Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Digital Solution to Improve Cognitive Function in Epilepsy: PRODDIGE Project', 'orgStudyIdInfo': {'id': '2020PI095'}, 'secondaryIdInfos': [{'id': '2020-A02482-37', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"application supervised by a psychologist via teleconsultations"', 'description': 'patient have app, and teleconsultation with psychologist', 'interventionNames': ['Behavioral: cognitive rehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': '"application in total autonomy"', 'description': 'patients have app, they play when they want', 'interventionNames': ['Behavioral: cognitive rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': '"control" group without using the application', 'description': "patients haven't app"}], 'interventions': [{'name': 'cognitive rehabilitation', 'type': 'BEHAVIORAL', 'description': 'patients have to use an app with cognitive games', 'armGroupLabels': ['"application in total autonomy"', '"application supervised by a psychologist via teleconsultations"']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'helene brissart, PhD, HDR', 'role': 'CONTACT', 'email': 'h.brissart@chru-nancy.fr', 'phone': '3383851689'}, {'name': 'louis maillard, Pr', 'role': 'CONTACT', 'email': 'l.maillard@chru-nancy.fr', 'phone': '383852377'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'UCB Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}