Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:15 AM
Study NCT ID:
NCT07471334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postictal psychotic symptoms', 'timeFrame': 'From enrollment until 2 months after video-EEG discharge', 'description': 'The percentage of patients presenting PPs after a video-EEG hospitalization. The diagnosis of PPs will be established based on a structured psychiatric clinical interview and the score obtained on the Brief Psychiatric Rating Scale (BPRS) (Adachi et al., 2024). This incidence will be compared with the 3% prevalence found in the literature. The BPRS is the reference scale in studies addressing psychotic symptoms in epilepsy and requires clinician scoring by a psychiatrist.'}], 'secondaryOutcomes': [{'measure': 'Risk factors associated with the occurrence of psychotic symptoms following video-EEG', 'timeFrame': 'From enrollment until 2 months after video-EEG discharge', 'description': 'Risk factors will be assessed based on variables related to the video-EEG hospitalization (e.g., number and type of seizures, presence of subclinical seizures, drug withdrawal), characteristics of epilepsy (type, focus, duration, seizure frequency, treatments), and psychiatric history or comorbidities.'}, {'measure': 'Psychometric properties and diagnostic performance of the Prodromal Questionnaire-16 (PQ-16)', 'timeFrame': 'From enrollment until 2 months after video-EEG discharge', 'description': 'Psychometric validation of the PQ-16 will involve assessing internal consistency, structural validity, and diagnostic performance. Analyses will identify an optimal cut-off score and calculate sensitivity, specificity, and positive and negative predictive values. The gold standard will be the diagnosis of PPs based on a psychiatric clinical interview and BPRS scoring.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postictal psychosis', 'epileptic psychoses', 'psychoses of epilepsy'], 'conditions': ['Focal Epilepsy With and Without Secondary Generalization', 'Psychotic Symptoms']}, 'referencesModule': {'references': [{'pmid': '35074723', 'type': 'BACKGROUND', 'citation': 'Tarrada A, Hingray C, Aron O, Dupont S, Maillard L, de Toffol B. Postictal psychosis, a cause of secondary affective psychosis: A clinical description study of 77 patients. Epilepsy Behav. 2022 Feb;127:108553. doi: 10.1016/j.yebeh.2022.108553. Epub 2022 Jan 21.'}, {'pmid': '31654941', 'type': 'BACKGROUND', 'citation': 'Tarrada A, Hingray C, Sachdev P, Le Thien MA, Kanemoto K, de Toffol B. Epileptic psychoses are underrecognized by French neurologists and psychiatrists. Epilepsy Behav. 2019 Nov;100(Pt A):106528. doi: 10.1016/j.yebeh.2019.106528. Epub 2019 Oct 24.'}, {'pmid': '40266083', 'type': 'BACKGROUND', 'citation': 'Shen S, Sun H, Dong Z, Yi T, Sander JW, Zhou D, Li J. Prevalence, clinical characteristics, and risk factors for psychosis in people with epilepsy: A multicenter retrospective cohort study. Epilepsia. 2025 Aug;66(8):2904-2915. doi: 10.1111/epi.18409. Epub 2025 Apr 23.'}, {'pmid': '32723705', 'type': 'BACKGROUND', 'citation': 'Grau-Lopez L, Jimenez M, Ciurans J, Gea M, Fumanal A, Caceres C, Garcia-Armengol R, Becerra JL. Clinical predictors of adverse events during continuous video-EEG monitoring in an epilepsy unit. Epileptic Disord. 2020 Aug 1;22(4):449-454. doi: 10.1684/epd.2020.1177.'}]}, 'descriptionModule': {'briefSummary': 'Psychotic disorders are up to eight times more prevalent in patients with epilepsy compared to the general population. Among them, postictal psychosis (PIP) is a severe complication of focal epilepsy, characterized by a brief psychotic episode emerging days after a seizure. This project investigates a potentially attenuated and under-recognized manifestation-postictal psychotic symptoms (PPs)-that may arise following hospitalization in a video-EEG monitoring unit and might serve as an early indicator for future PIP.\n\nWe hypothesize that the incidence of PPs is substantially higher than the 3% PIP prevalence reported in the literature and that their occurrence correlates with the intensity of epileptic activity triggered during video-EEG monitoring. The study has three main objectives: (1) to determine the incidence of PPs in patients with drug-resistant focal epilepsy, (2) to identify predictive factors associated with PPs, and (3) to assess the validity of the PQ-16 screening tool in this clinical context.\n\nA prospective monocentric study will be conducted in the video-EEG unit of Nancy University Hospital. One hundred and ten patients hospitalized for at least five days will be included. Psychiatric assessments will include standardized clinical interviews, Brief Psychiatric Rating Scale (BPRS) scoring, and self-report questionnaires. These evaluations will take place at three timepoints: baseline (V1), 3-5 days post-discharge (V2), and two months post-discharge (V3).\n\nThis study aims to facilitate the early identification of PPs and support the development of preventive strategies, ultimately improving psychiatric care and overall management in patients with epilepsy.', 'detailedDescription': 'The incidence of psychotic disorders during epilepsy is eight times higher than in the general population (Clancy et al., 2014). These disorders are classified according to their chronological link to seizures. A distinction is made between (1) peri-ictal disorders: occurring before, during, or after a seizure, and (2) interictal disorders: unrelated to the occurrence of a seizure. Among the peri-ictal disorders, postictal psychosis (PIP) constitutes a complication of epilepsy, marked by the sudden occurrence of a psychotic episode in the days following a seizure. During a PIP episode, delusional, hallucinatory, and manic symptoms are observed, often accompanied by significant agitation and, in some cases, violent behavior or self-harm. A study of 77 cases of PIP found that approximately one-third of the patients had committed a self- or other-directed act of aggression (Tarrada et al., 2022).\n\nOther studies, all retrospective, have highlighted several risk factors for PIP, such as long-standing drug-resistant focal temporal epilepsy (typically evolving over 15 to 20 years), seizure clusters, bilateral tonic-clonic generalization of seizures, and the presence of independent bilateral epileptic anomalies. The estimated prevalence of PIP is approximately 2% to 4% according to current literature. This complication appears to be more common following video-EEG hospitalizations, during which seizures may be intentionally provoked for diagnostic purposes. PIP therefore represents a significant and potentially severe complication of both epilepsy and video-EEG, underscoring the need for early detection to mitigate its consequences.\n\nAdditionally, it is very likely that patients may experience psychotic symptoms (hallucinations, delusional thoughts) in a milder form during the days following video-EEG, which could be predictive of future PIP episodes. These subthreshold postictal psychotic symptoms (PPs) are currently poorly understood, especially among non-specialist psychiatrists and neurologists, contributing to their under-recognition and underdiagnosis-particularly when symptoms do not reach the threshold of a fully developed PIP.\n\nThe hypotheses to be verified are as follows: (1) The incidence of PPs is significantly higher (at least fourfold) than the prevalence of PIP (3%) reported in the literature. (2) The incidence of PPs increases proportionally with the number of seizures induced during video-EEG monitoring.\n\nWe will conduct a prospective monocentric cohort study, based on regular psychiatric assessment and interventions, at the beginning of video-EEG hospitalization, and until 2 months after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of drug-resistant focal epilepsy\n* hospitalization for at least 5 days video-EEG (or SEEG) monitoring\n* capable of providing informed consent, able to communicate in French, and covered by a national health insurance plan\n\nExclusion Criteria:\n\n* Patients presenting with psychotic symptoms at baseline (V1), or who have had recent modifications (less than 15 days before admission) to their antiepileptic or psychotropic medications, will be excluded to reduce confounding factors in the assessment of postictal psychotic symptoms.'}, 'identificationModule': {'nctId': 'NCT07471334', 'acronym': 'INSPEV', 'briefTitle': 'Prospective Study of Postictal Psychotic Symptoms Occuring After Video-EEG Monitoring in Focal Epilepsies', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Incidence of Postictal Psychotic Symptoms After a Video-EEG Monitoring : Impact of Focal Epileptic Seizures', 'orgStudyIdInfo': {'id': '2024PI259'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychiatric prospective follow-up', 'interventionNames': ['Diagnostic Test: Psychiatric assessment']}], 'interventions': [{'name': 'Psychiatric assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Description of the experimental design Data Collection and Visits\n\n1. Visit 0 (V0): Patient information and consent collection after eligibility screening.\n2. Visit 1 (V1): Psychiatric evaluation at the start of hospitalization, prior to any tapering of antiepileptic treatment. If psychotic symptoms are detected at this stage, the patient will be excluded from the study.\n3. Visit 2 (V2): Psychiatric assessment 3-5 days after discharge from video-EEG hospitalization. This timing is based on the average latency for PIP onset.\n4. Visit 3 (V3): Final evaluation two months after discharge, corresponding to the maximum observed latency for PIP.\n\nEach visit includes:\n\n* A semi-structured psychiatric clinical interview (adapted from the Mini International Neuropsychiatric Interview, M.I.N.I.)\n* Clinician-rated assessment with the BPRS\n* Self-report questionnaires: for depression, anxiety and psychosis', 'armGroupLabels': ['Psychiatric prospective follow-up']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Alexis Tarrada, MD', 'role': 'CONTACT', 'email': 'a.tarrada@chru-nancy.fr', 'phone': '+33383852457'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'TARRADA Alexis', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}