Neuroimaging Biomarker for Seizures (NIBMSZS)

April 4, 2022 updated by: Providence VA Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 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.

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

Impact: This grant application for the first study investigating mechanisms of PNES and PTE will provide increased understanding of neural circuitry in PTE and PNES, which can inform PTE and PNES treatments and could change clinical neurologic and psychiatric practice for PTE and PNES.

Participants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02908
        • Providence VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: (CBT-Sz) - PNES
Participants with history of a head injury and confirmed Psychogenic Non-Epileptic Seizures will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist.
Behavioral: Cognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
Other Names:
  • Cognitive Behavioral Therapy (CBT-Sz)
  • (CBT-Sz) - PNES
  • (CBT-Sz) - PTE
EXPERIMENTAL: (CBT-Sz) - PTE
Participants with history of a head injury and confirmed Post-Traumatic Epilepsy (PTE) will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist.
Behavioral: Cognitive Behavioral Therapy for Seizures
CBT-informed psychotherapy for patients with PNES and PTE
Other Names:
  • Cognitive Behavioral Therapy (CBT-Sz)
  • (CBT-Sz) - PNES
  • (CBT-Sz) - PTE
ACTIVE_COMPARATOR: TBI Control
Participants with TBI will complete 2 brain fMRI scans.
Other: Standard Medical Care
Observational - standard medical care
Other Names:
  • Treatment as Usual
ACTIVE_COMPARATOR: Healthy Volunteer
Healthy control volunteers will complete 2 brain fMRI scans.
Other: Standard Medical Care
Observational - standard medical care
Other Names:
  • Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Epileptic Seizures
Time Frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar
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)
Time Frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar
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
Time Frame: Baseline and week 13
Brain MRI scans
Baseline and week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome.
Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Beck Anxiety Inventory (BAI)
Time Frame: Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline
The BDI-II assesses anxiety severity from "0" (no Anxiety-related symptom) to "3" (severe) on each question.
Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline
Quality of Life in Epilepsy-31 (QOLIE-31)
Time Frame: Baseline, Weeks 6 and 10
his is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Baseline, Weeks 6 and 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Providence VA Medical Center

Collaborators

University of Alabama at Birmingham
United States Department of Defense
Brown University
Rhode Island Hospital
Ocean State Research Institute, Inc.
Birmingham, Alabama VA Medical Center

Investigators

  • Principal Investigator: W. Curt LaFrance, Jr., MD, MPH, Providence VA Medical Center
  • Principal Investigator: Jerzy Szarflarski, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2017

Primary Completion (ANTICIPATED)

May 15, 2022

Study Completion (ANTICIPATED)

September 14, 2022

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Award Number W81XWH-17-1-0619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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