UnknownNot Applicable

Neuroimaging Biomarker for Seizures

United States224 participantsStarted 2017-09-15

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 psychoth…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Epileptic Seizures

Timeframe: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline

Number of Nonepileptic Seizures (NES)

Timeframe: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline

Structural and Functional Neuroimaging

Timeframe: Baseline and week 13

Trial details

NCT IDNCT03441867

SponsorProvidence VA Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2022-05-15

View on ClinicalTrials.gov More Seizure Disorder trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Epileptic Seizures

Timeframe: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline

Number of Nonepileptic Seizures (NES)

Timeframe: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline

Structural and Functional Neuroimaging

Timeframe: Baseline and week 13