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Study Protocol

Managing Functional Neurological Disorders: Protocol of a Cohort Study on Psychogenic Non-Epileptic Seizures Study

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Pages 3557-3568 | Published online: 27 Dec 2019
 

Abstract

Background

Functional neurological disorders (FNDs) are neurological symptoms that cannot be explained by an underlying neurological lesion or other medical illness and that do not have clear neuropathological correlates. Psychogenic non-epileptic seizures (PNES) are a common and highly disabling form of FND, characterized by paroxysmal episodes of involuntary movements and altered consciousness that can appear clinically similar to epileptic seizures. PNES are unique among FNDs in that they are diagnosed by video electroencephalographic (VEEG), a well-established biomarker for the disorder. The course of illness and response to treatment of PNES remain controversial. This study aims to describe the epidemiology of PNES in the Department of Veterans Affairs Healthcare System (VA), evaluate outcomes of veterans offered different treatments, and compare models of care for PNES.

Methods

This electronic health record (EHR) cohort study utilizes an informatics search tool and a natural language processing algorithm to identify cases of PNES nationally. We will use VA inpatient, outpatient, pharmacy, and chart abstraction data across all 170 medical centers to identify cases in fiscal years 2002–2018. Outcome measurements such as seizure frequency, emergency room visits, hospital admissions, suicide-related behavior, and the utilization of psychotherapy prior to and after PNES diagnosis will be used to assess the effectiveness of models of care.

Discussion

This study will describe the risk factors and course of treatment of a large cohort of people with PNES. Since PNES are cared for by a variety of different modalities, treatment orientations, and models of care, effectiveness outcomes such as seizure outcomes and utilization of emergency visits for seizures will be assessed. Outcome measurements such as seizure frequency, emergency room visits, hospital admissions, suicide-related behavior, and psychotherapy prior to and after PNES diagnosis will be used to assess the effectiveness of models of care.

Acknowledgments

We would like to thank members of the VA Connecticut Healthcare System Pain, Research, Informatics, Medical Comorbidities and Education Center of Innovation and the Yale Center for Neuroepidemiology and Clinical Neurological Research for their input and feedback.

Abbreviations

ACT, Acceptance and Commitment Therapy; CBT, Cognitive Behavioral Therapy; CDW, Corporate Data Warehouse; CPT, Current Procedural Terminology; DoD, Department of Defense; ECOE, Epilepsy Centers of Excellence; EHR, Electronic Health Records; FND, Functional Neurological Disorder; GEE, Generalized Estimating Equations; ICD, International Classification of Disease; ILAE, International League Against Epilepsy; MST, Military Sexual Trauma; NRS, Numeric Rating Scale; OEF, Operation Enduring Freedom; OIF, Operation Iraqi Freedom; OND, Operation New Dawn; PE, Prolonged Exposure; PNES, Psychogenic Non-Epileptic Seizures; PTPNES, Post-Traumatic PNES; PTSD, Post-Traumatic Stress Disorder; SSRI, Selective Serotonin Reuptake Inhibitor; TBI, Traumatic Brain Injury; VA, Veterans Affairs; VEEG, Video-Electroencephalogram.

Ethics Approval and Consent to Participate

Ethical approval was granted by the VA Connecticut Healthcare System Institutional Review Board and by the US Army Medical Research Human Research Protection Office.

Data Sharing Statement

The datasets generated and/or analyzed during the current study are not publicly available due to VA privacy and information security policies.

Author Contributions

HA, BF, MJP designed the project. HA secured funding for the project and was responsible for ethics approval. All authors contributed to the conception and design of the study, interpretation of data, draft composition and review, gave final approval of the version to be published, and agreed to be accountable for all aspects of the work.

Disclosure

Dr Daniela Galluzzo reports grants from Department of Defense, during the conduct of the study. Dr Yarden Bornovski reports grants from Congressionally Directed Medical Research Programs, during the conduct of the study. Dr Benjamin Tolchin reports grants from US Department of Veterans Affairs and CG Swebilius Trust, outside the submitted work. Dr Mary Jo Pugh reports grants from Brain Sentinal, outside the submitted work. Dr. Hamada Altalib has received research funding from Sunovion, Eisai, UCB, and Pfizer. Dr. Altalib has also served on the advisory board for Eisai. The authors report no other conflicts of interest in this work.

Additional information

Funding

The study is funded through the US Department of Defense Congressionally Directed Medical Research Programs (EP1600449).