Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT03441867
Eligibility Criteria:
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), 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03441867
Study Brief:
Protocol Section:
NCT03441867