Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-31 @ 5:57 PM
Study NCT ID:
NCT06922734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epilepsy Watch After Vascular Events: Frequency, Outcomes, and Risk Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-stroke seizure prevalence', 'timeFrame': 'From enrollment of first patient to the last one in 12 months'}, {'measure': 'Risk factors of post-stroke seizures', 'timeFrame': 'From enrollment of first patient to the last one in 12 months', 'description': 'Investigators are interested in serum and radiological biomarkers as risk factors for post-stroke seizures'}, {'measure': 'post-stroke EEG characteristics', 'timeFrame': 'From enrollment of first patient to the last one in 12 months', 'description': 'Investigators are interested in specific EEG changes which may indicate risk factors for post-stroke seizures'}], 'secondaryOutcomes': [{'measure': 'Aperiodic EEG component in patients after stroke with and without seizures', 'timeFrame': 'From enrollment to the end of hospitalisation', 'description': 'The parameters of the aperiodic EEG component in patients with epileptic seizures or epileptiform graphoelements in the EEG differ from patients without seizures or without epileptiform graphoelements and from the control group of healthy subjects.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'seizures', 'epilepsy', 'eeg', 'aperiodic component', 'serum biomarkers', 'CT scan', 'MRI'], 'conditions': ['Stroke', 'Seizures', 'EEG Power Spectra', 'Serum Biomarkers', 'CT Scan', 'MR Biomarkers']}, 'referencesModule': {'references': [{'pmid': '31008328', 'type': 'BACKGROUND', 'citation': 'Bentes C, Rodrigues FB, Sousa D, Duarte GS, Franco AC, Marques R, Nzwalo H, Peralta AR, Ferro JM, Costa J. Frequency of post-stroke electroencephalographic epileptiform activity - a systematic review and meta-analysis of observational studies. Eur Stroke J. 2017 Dec;2(4):361-368. doi: 10.1177/2396987317731004. Epub 2017 Sep 13.'}, {'pmid': '37754551', 'type': 'BACKGROUND', 'citation': 'Tatillo C, Legros B, Depondt C, Rikir E, Naeije G, Jodaitis L, Ligot N, Gaspard N. Prognostic value of early electrographic biomarkers of epileptogenesis in high-risk ischaemic stroke patients. Eur J Neurol. 2024 Jan;31(1):e16074. doi: 10.1111/ene.16074. Epub 2023 Sep 27.'}, {'pmid': '38759128', 'type': 'BACKGROUND', 'citation': 'Tanaka T, Ihara M, Fukuma K, Mishra NK, Koepp MJ, Guekht A, Ikeda A. Pathophysiology, Diagnosis, Prognosis, and Prevention of Poststroke Epilepsy: Clinical and Research Implications. Neurology. 2024 Jun 11;102(11):e209450. doi: 10.1212/WNL.0000000000209450. Epub 2024 May 17.'}, {'pmid': '36088797', 'type': 'BACKGROUND', 'citation': 'Pani SM, Saba L, Fraschini M. Clinical applications of EEG power spectra aperiodic component analysis: A mini-review. Clin Neurophysiol. 2022 Nov;143:1-13. doi: 10.1016/j.clinph.2022.08.010. Epub 2022 Aug 28.'}, {'pmid': '37611936', 'type': 'BACKGROUND', 'citation': 'Fukuma K, Tojima M, Tanaka T, Kobayashi K, Kajikawa S, Shimotake A, Kamogawa N, Ikeda S, Ishiyama H, Abe S, Morita Y, Nakaoku Y, Ogata S, Nishimura K, Koga M, Toyoda K, Matsumoto R, Takahashi R, Ikeda A, Ihara M. Periodic discharges plus fast activity on electroencephalogram predict worse outcomes in poststroke epilepsy. Epilepsia. 2023 Dec;64(12):3279-3293. doi: 10.1111/epi.17760. Epub 2023 Oct 30.'}], 'seeAlsoLinks': [{'url': 'https://www.ukc-mb.si/obvestila/projekti/interni-raziskovalni-projekti/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This research aims to determine the frequency of seizures in patients following a stroke, identify risk factors associated with post-stroke seizures, and characterize EEG changes linked to these seizures. Unexplored alterations in the aperiodic component of the EEG in post-stroke patients could potentially serve as novel biological markers for epilepsy after stroke.', 'detailedDescription': 'This study included patients with stroke or post-stroke seizures who were admitted to the Neurology Division at the University Medical Centre Maribor, Slovenia, over a 12-month period. The anticipated number of patients was approximately 600-650. Inclusion criteria encompassed acute stroke or seizure occurring at any point after the stroke. Stroke classification was based on the World Health Organization (WHO) criteria, while post-stroke seizures and epilepsy were defined according to the International League Against Epilepsy (ILAE) definitions and classifications.\n\nAll participants provided written informed consent after being thoroughly informed about the study. The study was pre-approved by the Medical Ethics Committee of the Republic of Slovenia (Approval No. 48/08/14 and Approval No. 0120-302/2024-2711-3). Patients who did not meet the inclusion criteria or could not undergo diagnostic procedures as outlined in the research protocol were excluded based on principles of good clinical practice.\n\nDuring the 12-month study period, demographic, imaging, laboratory, and neurophysiological data were prospectively collected from all hospitalized stroke patients.\n\nData Collection\n\nPatient history was utilized to gather information on neurological impairments, seizure onset, and risk factors for cerebrovascular diseases. For patients who experienced seizures, the interval between stroke onset and seizure occurrence (in days) was calculated to distinguish early from late post-stroke seizures.\n\nVital signs, including blood pressure, pulse, height, weight, and body mass index (BMI), were recorded. Neurological impairment was assessed on admission and discharge through clinical examinations and standardized scales, including the National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS).\n\nLaboratory and Diagnostic Assessments\n\nWithin 24 hours of admission, blood samples were collected to measure urea, creatinine, electrolytes, uric acid, cholesterol, triglycerides, liver enzymes, blood glucose, cystatin C, high-sensitivity C-reactive protein (hsCRP), red blood cell count, hemoglobin concentration, and urine analysis.\n\nWithin 72 hours of admission, imaging diagnostics (computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\] of the brain) and functional diagnostics (electroencephalography \\[EEG\\]) were performed. The study population consisted of patients with ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, and other rare cerebrovascular diseases (CVD).\n\nPatient Grouping\n\nClinical Seizure Data and Timing of Onset Post-Stroke:\n\nPatients were classified into three groups:\n\nNo seizures after stroke ("no EPI")\n\nEarly seizures (within 7 days post-stroke; "early EPI")\n\nLate seizures (more than 7 days post-stroke; "late EPI")\n\nEEG-Based Grouping:\n\nPatients were additionally grouped based on EEG results:\n\nEEG+/EPI+: Epileptiform EEG changes with seizures\n\nEEG+/EPI-: Epileptiform EEG changes without seizures\n\nEEG-/EPI-: No epileptiform EEG changes and no seizures\n\nKON: Control group of healthy individuals\n\nPlanned Analyses\n\nDemographic Analysis:\n\nData on gender, age, cerebrovascular risk factors, stroke type, functional impairment (assessed by NIHSS and mRS), seizure prevalence, and EEG changes were analyzed for all participants. Subgroup demographic analyses were performed based on clinical and EEG data.\n\nEEG Analysis:\n\nStandard visual EEG analysis included the evaluation of spectral frequency bands and the identification of focal or generalized epileptiform abnormalities. Preprocessing involved removing segments with noise, saturation, or absence of EEG activity. Ocular artifacts, including blink-related components, were identified using independent component analysis, and the EEG signals were reconstructed without these artifacts.\n\nUsing spectral parameterization (SPECPARAM 2.0 in Python), power spectral density was calculated for each patient. Aperiodic components were analyzed by extracting the exponent and offset from each frequency spectrum. Welch\'s t-tests were used to compare these parameters between groups. Additionally, standardized low-resolution brain electromagnetic tomography (sLORETA) was employed for signal source localization, micro-EEG potential analysis, and network distribution assessment.\n\nStatistical Data Analysis\n\nDescriptive Statistics:\n\nBasic descriptive metrics, including mean, standard deviation, median, minimum, maximum, and quartiles, were calculated for each variable to assess within-group distributions. Frequencies and relative frequencies were determined for categorical variables, with emphasis on the prevalence rates within the "no EPI," "early EPI," and "late EPI" groups. Results were presented in frequency tables.\n\nInferential Statistics:\n\nParametric tests (for normally distributed data):\n\nTwo-group comparisons: t-tests\n\nMulti-group comparisons: ANOVA\n\nNon-parametric tests (for non-normally distributed data):\n\nTwo-group comparisons: Mann-Whitney U tests\n\nMulti-group comparisons: Kruskal-Wallis tests\n\nFor EEG-based groups, extracted offset and exponent values of aperiodic components were compared using Welch\'s t-tests. Correlation analyses (Pearson\'s or Spearman\'s) were performed based on data distribution. Post-hoc analyses used Dunn\'s tests for pairwise comparisons when significant differences were identified.\n\nCategorical Data Analysis:\n\nChi-square tests evaluated differences between categorical variables among patient groups. Fisher\'s exact test was applied when expected frequencies were too low for the chi-square test.\n\nSurvival Analysis:\n\nTo examine seizure onset timing, survival analysis was conducted using the time from stroke onset as the time variable. Kaplan-Meier analysis estimated survival curves representing seizure-free intervals, and log-rank (Mantel-Cox) tests were used to compare survival distributions across groups. This analysis helped to identify factors associated with seizure onset timing among stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study included 602 patients with acute stroke or post-stroke seizures who were admitted to the Neurology Division at the University Medical Centre Maribor over a 12-month period.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients were eligible for inclusion if they had experienced an acute stroke or a seizure occurring at any point after a previous stroke.\n\nExclusion Criteria:\n\nPatients were excluded from the study if they did not meet the inclusion criteria or if diagnostic procedures could not be performed in accordance with the research protocol. Exclusions were made following good clinical practice principles.'}, 'identificationModule': {'nctId': 'NCT06922734', 'acronym': 'EY-WAVEFORMS', 'briefTitle': 'Epilepsy Watch After Vascular Events: Frequency, Outcomes, and Risk Markers', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Maribor'}, 'officialTitle': 'Post-stroke Seizures and EEG Analysis', 'orgStudyIdInfo': {'id': 'KME št. 0120-302/2024-2711-3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EEG+/EPI+ group', 'description': 'Patients with epileptiform EEG changes and seizures'}, {'label': 'EEG+/EPI- group', 'description': 'Patients with epileptiform EEG changes but no seizures'}, {'label': 'EEG-/EPI-group', 'description': 'Patients without epileptiform EEG changes and no seizures'}, {'label': 'KON group', 'description': 'A control group of comparable healthy individuals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Maribor', 'country': 'Slovenia', 'facility': 'UKC Maribor', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}], 'overallOfficials': [{'name': 'Martin Rakusa, Asoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'UKC Maribor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Due to national laws we can't share data from this study."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Maribor', 'class': 'OTHER'}, 'collaborators': [{'name': 'IRCCS San Camillo, Venezia, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Senior Consultant Neurologist', 'investigatorFullName': 'Albin Gačnik MD', 'investigatorAffiliation': 'University Medical Centre Maribor'}}}}