Study Results
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Basic Information
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UNKNOWN
NA
224 participants
INTERVENTIONAL
2017-09-15
2022-09-14
Brief Summary
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Detailed Description
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In 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.
Impact: 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.
Participants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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(CBT-Sz) - PNES
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.
Cognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
(CBT-Sz) - PTE
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.
Cognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
TBI Control
Participants with TBI will complete 2 brain fMRI scans.
Standard Medical Care
Observational - standard medical care
Healthy Volunteer
Healthy control volunteers will complete 2 brain fMRI scans.
Standard Medical Care
Observational - standard medical care
Interventions
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Cognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
Standard Medical Care
Observational - standard medical care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males and Females ages 18-60 years .
* Women of child bearing potential, if currently using appropriate contraception.
* Diagnosed by video/EEG with lone PNES or by EEG with lone ES.
* Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.
Exclusion Criteria
* Current suicidal intent (BDI suicide question 9 score of \>1).
* Current or past year psychosis.
* Pending litigation or current application for long term disability.
* Active substance or alcohol use disorder (dependence), per discretion of the investigators.
* 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.
* Inability to fill out the self-report surveys.
* Women who are or/are attempting to become pregnant during the study.
* Ineligible or unwilling to complete MRI imaging.
* Inability to document TBI.
* Inability or unwillingness to participate in CBT and assigned homework.
* Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered).
* Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Rhode Island Hospital
OTHER
Birmingham, Alabama VA Medical Center
FED
United States Department of Defense
FED
Ocean State Research Institute, Inc.
OTHER
Brown University
OTHER
Providence VA Medical Center
FED
Responsible Party
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Principal Investigators
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W. Curt LaFrance, Jr., MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Providence VA Medical Center
Jerzy Szarflarski, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Providence VA Medical Center
Providence, Rhode Island, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Award Number W81XWH-17-1-0619
Identifier Type: -
Identifier Source: org_study_id
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