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Cognitive Behavioral Therapy for Seizures for Seizure Disorder (NIBMSZS Trial)

N/A
Waitlist Available
Led By W. Curt LaFrance, Jr., MD, MPH
Research Sponsored by Providence VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Awards & highlights

NIBMSZS Trial Summary

This trial will compare brain function in patients with epilepsy following head injury, patients with posttraumatic seizures not related to epilepsy, and patients with traumatic brain injury who don't have seizures.

Eligible Conditions
  • Magnetic Resonance Imaging (MRI)
  • Seizure Disorder
  • Epilepsy
  • Traumatic Brain Injury
  • Nonepileptic Seizures
  • Conversion Disorder

NIBMSZS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Epileptic Seizures
Number of Nonepileptic Seizures (NES)
Structural and Functional Neuroimaging
Secondary outcome measures
Beck Anxiety Inventory (BAI)
Beck Depression Inventory-II (BDI-II)
Quality of Life in Epilepsy-31 (QOLIE-31)

NIBMSZS Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: (CBT-Sz) - PTEExperimental Treatment1 Intervention
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.
Group II: (CBT-Sz) - PNESExperimental Treatment1 Intervention
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.
Group III: TBI ControlActive Control1 Intervention
Participants with TBI will complete 2 brain fMRI scans.
Group IV: Healthy VolunteerActive Control1 Intervention
Healthy control volunteers will complete 2 brain fMRI scans.

Find a Location

Who is running the clinical trial?

Ocean State Research Institute, Inc.OTHER
2 Previous Clinical Trials
80 Total Patients Enrolled
Providence VA Medical CenterLead Sponsor
26 Previous Clinical Trials
72,229 Total Patients Enrolled
Brown UniversityOTHER
456 Previous Clinical Trials
558,120 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
BrainJournal
Emotional Stimuli and Motor Conversion Disorder
Voon, V., C. Brezing, C. Gallea, R. Ameli, K. Roelofs, W. C. LaFrance, and M. Hallett. 2010. “Emotional Stimuli and Motor Conversion Disorder”. Brain. Oxford University Press (OUP). doi:10.1093/brain/awq054.
clinicaltrials.govStudy
Neuroimaging Biomarker for Seizures
2017. "Neuroimaging Biomarker for Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03441867.
~30 spots leftby Apr 2025
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