Neuroimaging Biomarker for Seizures (NIBMSZS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03441867 |
|
Recruitment Status :
Recruiting
First Posted : February 22, 2018
Last Update Posted : September 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Seizure Disorder Seizure Disorder, Post Traumatic Traumatic Brain Injury Non-Epileptic Seizure Conversion Disorder Magnetic Resonance Imaging Head Injury Epilepsy | Behavioral: Cognitive Behavioral Therapy for Seizures Other: Standard Medical Care | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 264 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | The neuroimaging analysis will be masked. |
| Primary Purpose: | Treatment |
| Official Title: | Neuroimaging Biomarker for Seizures |
| Actual Study Start Date : | September 15, 2017 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | September 30, 2022 |
| 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:
|
|
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:
|
|
Active Comparator: TBI Control
Participants with TBI will complete 2 brain fMRI scans.
|
Other: Standard Medical Care
Observational - standard medical care
Other Name: 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 Name: Treatment as Usual |
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441867
| Contact: W. Curt LaFrance, Jr., MD, MPH | 401-273-7100 | william_lafrance_jr@brown.edu | |
| Contact: Krista Tocco, BA | 401-273-7100 ext 16229 | Krista.Tocco@va.gov |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Samantha Fry 205-975-9804 sdfry@uabmc.edu | |
| Principal Investigator: Jerzy Szaflarski, MD, PhD | |
| Sub-Investigator: Jane Allendorfer, PhD | |
| Sub-Investigator: Mark Bolding, PhD | |
| Sub-Investigator: Lawrence Ver Hoef, MD | |
| Sub-Investigator: Tyler Gaston, MD | |
| Sub-Investigator: Leslie Grayson, MD | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Krista Tocco 401-484-0127 KTocco@lifespan.org | |
| Principal Investigator: Andrew Blum, MD | |
| Sub-Investigator: Jason Machan, PhD | |
| Providence VA Medical Center | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: Krista Tocco 401-273-7100 ext 16229 Krista.Tocco@va.gov | |
| Principal Investigator: W. Curt LaFrance, Jr., MD, MPH | |
| Sub-Investigator: Noah Philip, MD | |
| Sub-Investigator: Stephen Correia, PhD | |
| Principal Investigator: | W. Curt LaFrance, Jr., MD, MPH | Providence VA Medical Center | |
| Principal Investigator: | Jerzy Szarflarski, MD | University of Alabama at Birmingham |
Documents provided by Providence VA Medical Center:
| Responsible Party: | Providence VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT03441867 |
| Other Study ID Numbers: |
Award Number W81XWH-17-1-0619 |
| First Posted: | February 22, 2018 Key Record Dates |
| Last Update Posted: | September 5, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Cognitive Behavioral Therapy Veterans Quality of Life Stress Disorders, Post-Traumatic |
Convulsion, Non-Epileptic civilians healthy volunteers |
|
Brain Injuries Epilepsy Brain Injuries, Traumatic Seizures Craniocerebral Trauma Epilepsy, Post-Traumatic Disease Wounds and Injuries Conversion Disorder Hysteria Dissociative Disorders |
Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Neurologic Manifestations Somatoform Disorders Mental Disorders Histrionic Personality Disorder Personality Disorders |