An interventional study of Cognitive Behavioral Therapy for Seizures and Standard Medical Care in Seizure Disorder, Seizure Disorder, Post Traumatic and Traumatic Brain Injury, sponsored by Providence VA Medical Center. Status unknown at 3 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.
Sponsored by Providence VA Medical Center · Not applicable, Interventional, and Treatment
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.
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.
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).
Inclusion Criteria:
Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants
Inclusion criteria of PNES and ES participants.
Exclusion Criteria:
Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants
Exclusion Criteria for PNES and ES participants
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.
Behavioral: Cognitive Behavioral Therapy for Seizures
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.
Behavioral: Cognitive Behavioral Therapy for Seizures
Participants with TBI will complete 2 brain fMRI scans.
Other: Standard Medical Care
Healthy control volunteers will complete 2 brain fMRI scans.
Other: Standard Medical Care
CBT-informed psychotherapy for patients with PNES and PTE
Also known as: Cognitive Behavioral Therapy (CBT-Sz), (CBT-Sz) - PNES, (CBT-Sz) - PTE
Observational - standard medical care
Also known as: Treatment as Usual
Number of Epileptic Seizures
epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Number of Nonepileptic Seizures (NES)
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Structural and Functional Neuroimaging
Brain MRI scans
Time frame: Baseline and week 13
Beck Depression Inventory-II (BDI-II)
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.
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Beck Anxiety Inventory (BAI)
The BDI-II assesses anxiety severity from "0" (no Anxiety-related symptom) to "3" (severe) on each question.
Time frame: Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline
Quality of Life in Epilepsy-31 (QOLIE-31)
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.
Time frame: Baseline, Weeks 6 and 10
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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Providence VA Medical Center