Neuroimaging Biomarker for Seizures

Status unconfirmed · Not applicable

Conditions studied: Seizure Disorder, Seizure Disorder, Post Traumatic, Traumatic Brain Injury, Non-Epileptic Seizure, Conversion Disorder, Magnetic Resonance Imaging, Head Injury, Epilepsy

In brief

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.

Key facts

Study ID

NCT03441867

Run by

Providence VA Medical Center

People needed

224

Starts

2017-09-15

Expected to finish

2022-09-14

Last updated by the study team

2022-04-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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