Conversion Disorder, Epilepsy, Head Injury, Magnetic Resonance Imaging, Non-Epileptic Seizure, Seizure Disorder, Seizure Disorder, Post Traumatic, Traumatic Brain Injury
Conditions
Keywords
Cognitive Behavioral Therapy, Veterans, Quality of Life, Stress Disorders, Post-Traumatic, Convulsion, Non-Epileptic, civilians, healthy volunteers
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALCognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
OTHERStandard Medical Care
Observational - standard medical care
Sponsors
University of Alabama at Birmingham
Rhode Island Hospital
Birmingham, Alabama VA Medical Center
United States Department of Defense
Ocean State Research Institute, Inc.
Brown University
Providence VA Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The neuroimaging analysis will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants * Individuals with history of documented TBI (any severity). * Males and Females ages 18-60 years . * Women of child bearing potential, if currently using appropriate contraception. Inclusion criteria of PNES and ES participants. * 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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Epileptic Seizures | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar |
| Number of Nonepileptic Seizures (NES) | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar |
| Structural and Functional Neuroimaging | Baseline and week 13 | Brain MRI scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline | 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. |
| Beck Anxiety Inventory (BAI) | Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline | The BDI-II assesses anxiety severity from 0 (no Anxiety-related symptom) to 3 (severe) on each question. |
| Quality of Life in Epilepsy-31 (QOLIE-31) | Baseline, Weeks 6 and 10 | 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. |
Countries
United States
Outcome results
None listed