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Neuroimaging Biomarker for Seizures (NIBMSZS)

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ClinicalTrials.gov Identifier: NCT03441867
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
University of Alabama at Birmingham
Rhode Island Hospital
Birmingham, Alabama VA Medical Center
United States Department of Defense
Ocean State Research Institute, Inc.
Brown University
Information provided by (Responsible Party):
Providence VA Medical Center

Tracking Information
First Submitted Date  ICMJE December 29, 2017
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
  • 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
  • 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
  • Structural and Functional Neuroimaging [ Time Frame: Baseline and week 13 ]
    Brain MRI scans
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Evaluate decrease in seizure frequency captured by weekly seizure calendars. [ Time Frame: For 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Biomarker for Seizures
Official Title  ICMJE Neuroimaging Biomarker for Seizures
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 them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
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 176 Veterans will be compared to 88 Veterans 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
The neuroimaging analysis will be masked.
Primary Purpose: Treatment
Condition  ICMJE
  • Seizure Disorder
  • Seizure Disorder, Post Traumatic
  • Traumatic Brain Injury
  • Non-Epileptic Seizure
  • Conversion Disorder
  • Magnetic Resonance Imaging
Intervention  ICMJE
  • 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
  • Other: Standard Medical Care
    Observational - standard medical care
    Other Name: Treatment as Usual
Study Arms  ICMJE
  • Experimental: (CBT-Sz) - PNES
    Participants with history of a head injury and confirmed PNES will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist.
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy for Seizures
    • Other: Standard Medical Care
  • 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.
    Interventions:
    • Behavioral: Cognitive Behavioral Therapy for Seizures
    • Other: Standard Medical Care
  • Active Comparator: TBI Control
    Participants with TBI will complete 2 brain fMRI scans.
    Intervention: Other: Standard Medical Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: W. Curt LaFrance, Jr., MD, MPH 401-273-7100 ext 2441 william_lafrance_jr@brown.edu
Contact: Krista Tocco, BA 401-273-7100 ext 6229 Krista.Tocco@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03441867
Other Study ID Numbers  ICMJE Award Number W81XWH-17-1-0619
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Providence VA Medical Center
Study Sponsor  ICMJE Providence VA Medical Center
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • Rhode Island Hospital
  • Birmingham, Alabama VA Medical Center
  • United States Department of Defense
  • Ocean State Research Institute, Inc.
  • Brown University
Investigators  ICMJE
Principal Investigator: W. Curt LaFrance, Jr., MD, MPH Providence VA Medical Center
Principal Investigator: Jerzy Szarflarski, MD University of Alabama at Birmingham
PRS Account Providence VA Medical Center
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP