Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT03441867
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2017-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroimaging Biomarker for Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-10', 'releaseDate': '2025-05-27'}, {'resetDate': '2025-07-31', 'releaseDate': '2025-07-14'}], 'estimatedResultsFirstSubmitDate': '2025-05-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D004834', 'term': 'Epilepsy, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D003291', 'term': 'Conversion Disorder'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-06', 'size': 254290, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-17T10:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The neuroimaging analysis will be masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2017-12-29', 'studyFirstSubmitQcDate': '2018-02-15', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Epileptic Seizures', 'timeFrame': 'Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline', 'description': 'epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar'}, {'measure': 'Number of Nonepileptic Seizures (NES)', 'timeFrame': 'Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline', 'description': 'psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar'}, {'measure': 'Structural and Functional Neuroimaging', 'timeFrame': 'Baseline and week 13', 'description': 'Brain MRI scans'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline', 'description': 'The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline', 'description': 'The BDI-II assesses anxiety severity from "0" (no Anxiety-related symptom) to "3" (severe) on each question.'}, {'measure': 'Quality of Life in Epilepsy-31 (QOLIE-31)', 'timeFrame': 'Baseline, Weeks 6 and 10', 'description': 'his is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Behavioral Therapy', 'Veterans', 'Quality of Life', 'Stress Disorders, Post-Traumatic', 'Convulsion, Non-Epileptic', 'civilians', 'healthy volunteers'], 'conditions': ['Seizure Disorder', 'Seizure Disorder, Post Traumatic', 'Traumatic Brain Injury', 'Non-Epileptic Seizure', 'Conversion Disorder', 'Magnetic Resonance Imaging', 'Head Injury', 'Epilepsy']}, 'referencesModule': {'references': [{'pmid': '24989152', 'type': 'BACKGROUND', 'citation': 'LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817.'}, {'pmid': '21893668', 'type': 'BACKGROUND', 'citation': 'Salinsky M, Spencer D, Boudreau E, Ferguson F. Psychogenic nonepileptic seizures in US veterans. Neurology. 2011 Sep 6;77(10):945-50. doi: 10.1212/WNL.0b013e31822cfc46.'}, {'pmid': '19562779', 'type': 'BACKGROUND', 'citation': 'LaFrance WC Jr, Friedman JH. Cognitive behavioral therapy for psychogenic movement disorder. Mov Disord. 2009 Sep 15;24(12):1856-7. doi: 10.1002/mds.22683. No abstract available.'}, {'pmid': '20739647', 'type': 'BACKGROUND', 'citation': 'LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.'}, {'pmid': '10775516', 'type': 'BACKGROUND', 'citation': 'Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. doi: 10.1053/seiz.1999.0374.'}, {'pmid': '22056814', 'type': 'BACKGROUND', 'citation': 'Elsas SM, Gregory WL, White G, Navarro G, Salinsky MC, Andrews DJ. Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial. Epilepsy Behav. 2011 Dec;22(4):765-72. doi: 10.1016/j.yebeh.2011.09.030. Epub 2011 Nov 6.'}, {'pmid': '22341960', 'type': 'BACKGROUND', 'citation': 'Michaelis R, Schonfeld W, Elsas SM. Trigger self-control and seizure arrest in the Andrews/Reiter behavioral approach to epilepsy: a retrospective analysis of seizure frequency. Epilepsy Behav. 2012 Mar;23(3):266-71. doi: 10.1016/j.yebeh.2011.11.023. Epub 2012 Feb 15.'}, {'pmid': '25306199', 'type': 'BACKGROUND', 'citation': 'Allendorfer JB, Szaflarski JP. Physiologic and cortical response to acute psychosocial stress in left temporal lobe epilepsy: response to a biochemical evaluation. Epilepsy Behav. 2014 Dec;41:312-3. doi: 10.1016/j.yebeh.2014.08.018. Epub 2014 Oct 11. No abstract available.'}, {'pmid': '11094115', 'type': 'BACKGROUND', 'citation': 'Szaflarski JP, Ficker DM, Cahill WT, Privitera MD. Four-year incidence of psychogenic nonepileptic seizures in adults in hamilton county, OH. Neurology. 2000 Nov 28;55(10):1561-3. doi: 10.1212/wnl.55.10.1561.'}, {'pmid': '19652140', 'type': 'BACKGROUND', 'citation': 'LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.'}, {'pmid': '12558580', 'type': 'BACKGROUND', 'citation': 'Szaflarski JP, Hughes C, Szaflarski M, Ficker DM, Cahill WT, Li M, Privitera MD. Quality of life in psychogenic nonepileptic seizures. Epilepsia. 2003 Feb;44(2):236-42. doi: 10.1046/j.1528-1157.2003.35302.x.'}, {'pmid': '20371508', 'type': 'BACKGROUND', 'citation': 'Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5.'}, {'pmid': '40996372', 'type': 'DERIVED', 'citation': 'Van Patten R, Cotton E, Chan L, Altalib H, Tocco K, Gaston TE, Grayson LP, Martin A, Fry S, Goodman A, Allendorfer JB, Blum A, Szaflarski JP, LaFrance WC Jr. Neurobehavioral Therapy Is Associated With Improvements in Social Functioning in Patients With Functional Seizures and Traumatic Brain Injury. J Clin Psychol. 2025 Sep 25. doi: 10.1002/jclp.70047. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This multi-site study will examine patients with epilepsy (ES) following head injury \\[i.e., posttraumatic epilepsy (PTE)\\] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.', 'detailedDescription': 'Numerous Veterans and civilians have seizures, which can be epileptic or nonepileptic in nature. Epileptic seizures are caused by abnormal brain cell firing. Nonepileptic seizures appear similar to epileptic seizures, but are associated with traumatic experiences and underlying psychological stressors. Both types of seizure are common and disabling, and many patients with seizures do not have adequate control resulting in loss of quality of life.\n\nIn this proposed 3-site study ( Providence, RI and Birmingham, AL), which are epilepsy centers with expertise both in epilepsy and psychogenic nonepileptic seizures (PNES), we will enroll 88 patients with video-EEG confirmed PNES and 88 with confirmed post-traumatic epilepsy (PTE) and will obtain functional neuroimaging before and after they receive a behavioral treatment - Cognitive Behavioral Therapy for Seizures. The functional neuroimaging studies in these patients will be compared to patients with traumatic brain injury without seizures to test the hypothesis that the faulty processing of emotions and stress in patients with PNES/PTE and abnormal brain connectivity have unique signals in patients with seizures compared to Veterans without seizures and that the neuroimaging signatures can be modified using behavioral intervention.\n\nImpact: This grant application for the first study investigating mechanisms of PNES and PTE will provide increased understanding of neural circuitry in PTE and PNES, which can inform PTE and PNES treatments and could change clinical neurologic and psychiatric practice for PTE and PNES.\n\nParticipants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants\n\n * Individuals with history of documented TBI (any severity).\n * Males and Females ages 18-60 years .\n * Women of child bearing potential, if currently using appropriate contraception.\n\nInclusion criteria of PNES and ES participants.\n\n* Diagnosed by video/EEG with lone PNES or by EEG with lone ES.\n* Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.\n\nExclusion Criteria:\n\n* Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants\n\n * Current or past year self-injurious behavior.\n * Current suicidal intent (BDI suicide question 9 score of \\>1).\n * Current or past year psychosis.\n * Pending litigation or current application for long term disability.\n * Active substance or alcohol use disorder (dependence), per discretion of the investigators.\n * Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry.\n * Inability to fill out the self-report surveys.\n * Women who are or/are attempting to become pregnant during the study.\n * Ineligible or unwilling to complete MRI imaging.\n * Inability to document TBI.\n\nExclusion Criteria for PNES and ES participants\n\n* Inability or unwillingness to participate in CBT and assigned homework.\n* Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered).\n* Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled.'}, 'identificationModule': {'nctId': 'NCT03441867', 'acronym': 'NIBMSZS', 'briefTitle': 'Neuroimaging Biomarker for Seizures', 'organization': {'class': 'FED', 'fullName': 'Providence VA Medical Center'}, 'officialTitle': 'Neuroimaging Biomarker for Seizures', 'orgStudyIdInfo': {'id': 'Award Number W81XWH-17-1-0619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(CBT-Sz) - PNES', 'description': 'Participants with history of a head injury and confirmed Psychogenic Non-Epileptic Seizures will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Seizures']}, {'type': 'EXPERIMENTAL', 'label': '(CBT-Sz) - PTE', 'description': 'Participants with history of a head injury and confirmed Post-Traumatic Epilepsy (PTE) will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Seizures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TBI Control', 'description': 'Participants with TBI will complete 2 brain fMRI scans.', 'interventionNames': ['Other: Standard Medical Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteer', 'description': 'Healthy control volunteers will complete 2 brain fMRI scans.', 'interventionNames': ['Other: Standard Medical Care']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy for Seizures', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy (CBT-Sz)', '(CBT-Sz) - PNES', '(CBT-Sz) - PTE'], 'description': 'CBT-informed psychotherapy for patients with PNES and PTE', 'armGroupLabels': ['(CBT-Sz) - PNES', '(CBT-Sz) - PTE']}, {'name': 'Standard Medical Care', 'type': 'OTHER', 'otherNames': ['Treatment as Usual'], 'description': 'Observational - standard medical care', 'armGroupLabels': ['Healthy Volunteer', 'TBI Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02908', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Providence VA Medical Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'W. Curt LaFrance, Jr., MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence VA Medical Center'}, {'name': 'Jerzy Szarflarski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'Rhode Island Hospital', 'class': 'OTHER'}, {'name': 'Birmingham, Alabama VA Medical Center', 'class': 'FED'}, {'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Ocean State Research Institute, Inc.', 'class': 'OTHER'}, {'name': 'Brown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-27', 'type': 'RELEASE'}, {'date': '2025-06-10', 'type': 'RESET'}, {'date': '2025-07-14', 'type': 'RELEASE'}, {'date': '2025-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Providence VA Medical Center'}}}}