Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-29 @ 7:07 AM
Study NCT ID:
NCT04810832
Status:
UNKNOWN
Last Update Posted:
2021-07-09
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open and prospective study.\n\nEvoked related potentials are recorded on the scalp and with intracranial electrodes for each participant while they listen 3 paradigms successively and in a random order:\n\ni) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2023-09-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latencies cartography of intracranial responses to own-name uttered by neutral voice', 'timeFrame': '1 year', 'description': 'Analyse of latencies of intracranial responses recorded to own-name uttered by neutral voice to build a map of the brain process of this responses'}, {'measure': 'Latencies cartography of intracranial responses to own-name uttered by expressive voices', 'timeFrame': '1 year', 'description': 'Analyse of latencies of intracranial responses recorded to own-name uttered by expressive voices to build a map of the brain process of this responses'}], 'secondaryOutcomes': [{'measure': 'Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes', 'timeFrame': '1 year', 'description': 'Qualitative comparison between scalp and intracranial recordings with the expressive voices paradigms (comparison of the latencies of the recorded responses)'}, {'measure': 'Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes', 'timeFrame': '1 year', 'description': 'Qualitative comparison between scalp and intracranial recordings with the neutral voices paradigms (comparison of the latencies of the recorded responses)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Event-related Potentials (ERP)', 'Intracerebral recordings', 'Presurgical evaluation'], 'conditions': ['Intractable Epilepsy']}, 'descriptionModule': {'briefSummary': 'Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.\n\nHere the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.', 'detailedDescription': 'Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient.\n\nIn human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices should involves more widespread brain areas than neutral voices processing.\n\nHere the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp to own-name stimuli uttered by neutral and more expressive voices (positive : smiling voice or negative : rough voice) in adult pharmacoresistant epilepsy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intractable focal epilepsy with undergoing pre-surgical evaluation\n* intracerebral electrodes implantation in auditory cortices, temporal lobe, superior temporal gyrus, limbic areas, frontal lobe\n* Given Consent to inclusion\n\nExclusion Criteria:\n\n* Deafness\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04810832', 'acronym': 'EXPRESON-IN', 'briefTitle': 'EXPRESON-IN : Intracerebral Recordings of P3a Responses to Expressive Own-names', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier St Anne'}, 'officialTitle': 'EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients', 'orgStudyIdInfo': {'id': '2020-A01340-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Whole group', 'description': 'The whole group undergo the two phases of the study:\n\n* 1/ They listen successively the 3 oddball paradigms in the department of neurophysiology : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice\n* 2/ They listen successively the same 3 oddball paradigms in the neurosurgical department, during their intractable epilepsy presurgical evaluation : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice', 'interventionNames': ['Other: Evoked related potentials']}], 'interventions': [{'name': 'Evoked related potentials', 'type': 'OTHER', 'description': 'Evoked related potentials are performed for each patient during each paradigm (neutral voice and expressive voices):\n\n* with scalp electrodes in the department of neurophysiology\n* with intracranial electrodes in the department of neurosurgery.', 'armGroupLabels': ['Whole group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'GHU Paris - Sainte Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier St Anne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}