Status:
UNKNOWN
Neuroimaging Biomarker for Seizures
Lead Sponsor:
Providence VA Medical Center
Collaborating Sponsors:
University of Alabama at Birmingham
Rhode Island Hospital
Conditions:
Seizure Disorder
Seizure Disorder, Post Traumatic
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
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 ep...
Eligibility Criteria
Inclusion
- 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
- 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), 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.
- 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.
Key Trial Info
Start Date :
September 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03441867
Start Date
September 15 2017
End Date
September 14 2022
Last Update
April 5 2022
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
3
Providence VA Medical Center
Providence, Rhode Island, United States, 02908