August 17, 2018

Clinical Trial: Neuroimaging Biomarker for Seizures (NIBMSZS)

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.

This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., post-traumatic epilepsy (PTE)] and post-traumatic psychogenic non-epileptic seizures (PNES), and will compare these patients to those with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

In this proposed 3-site study (Providence, RI and Birmingham, AL), which are epilepsy centers with expertise both in epilepsy and 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 176 Veterans will be compared to 88 Veterans 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.

Eligibility Criteria

Ages Eligible for Study: 18 Years to 60 Years (Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

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:

  • Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants
    • Current or past year self-injurious behavior
    • 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), in past 3 months
    • 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
  • Exclusion Criteria for PNES and ES participants
    • 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

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