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Epilepsy Clinical Research

Women’s Epilepsy Research

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
This multi-center, observational cohort study will enroll pregnant women with epilepsy, non-pregnant women with epilepsy, and pregnant healthy controls. Primary aims include maternal seizure frequency, obstetric complications, neonatal outcomes, maternal depression, and cognitive outcomes of the offspring, with consideration of AED pharmacokinetics and maternal and fetal exposure to AEDs.

Women with Epilepsy: Pregnancy Outcomes and Deliveries (WEPOD)
Determine if pregnancy rates differ in WWE compared to WWoE and what key factors contribute to these differences, and compare seizure frequency during preconception to seizure frequency during pregnancy, with analysis of covariates of interest.

Pharmacogenomics and Pharmacokinetics of Lamotrigine in Early Pregnancy (P-PEP)
This supplement to the WEPOD study will examine the impact of genetic variations in drug transporter ABCB1 and glucuronidating enzymes on baseline and accelerated lamotrigine clearance during early pregnancy, and describe the time course of change in lamotrigine concentrations during the first trimester of pregnancy and relate it to seizure frequency.

Neuroactive Steroids and Seizure Control during Pregnancy in Women with Epilepsy
This study will use serum and plasma samples collected from 135 pregnant women with epilepsy during a prior research study for the following hormones: estradiol (EST), progesterone (PRO), and allopregnanolone (ALLO). The following will be analyzed in relationship to change in seizure frequency during pregnancy: EST/PRO ratio and the rate of rise of PRO and ALLO levels.

Clinical Therapeutic Trials

The Division of EEG, Epilepsy, and Sleep Medicine is actively conducting clinical trials of the latest pharmaceutical agents. The following are the active trials enrolling patients:

EQUIGEN (Equivalence Among Antiepileptic Drug Generic and Brand Products in People with Epilepsy: Chronic-Dose 4-Period Replicate Design)

This multi-center study will enroll patients with epilepsy currently receiving balanced lamotrigine and will study 4 periods, 2 with “low range” generic and 2 with “ high range” generic. Pill counts and MEMS caps will be used. 12-hour PK sampling will be performed in the CCI every two weeks.

Double-Blind, Randomized, Historical Control Study of Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current AEDs
This is a double blind randomized trial of patients with poorly controlled epilepsy who are on one or two AEDs. The patients are randomized into one of two doses of the novel AED eslicarbazepine monotherapy after which control of seizures is evaluated. Enrolled goal has been met.

Long-term Eslicarbazepine Acetate Extension Study: Protocol 093-050
To evaluate the 1-year and post-1-year safety and tolerability of eslicarbazepine acetate flexible dosing within the range of 800 mg to 2400 mg in subjects with partial epilepsy who have participated in an 18-week double-blind eslicarbazepine acetate monotherapy study

Intravenous lacosamide compared with fosphenytoin in the treatment of patients with frequent nonconvulsive seizures
Multi-center study in which patients with acute electrographic seizures are open label randomized to either receiving fosphenytoin or lacosamide intravenously. This is an extremely important, novel trial as there is no evidence of any AEDs for electrographic seizures. We are currently enrolling.

Open label trial of add on lacosamide versus high dose monotherapy in patients with a seizure disorder
An investigator-initiated trial. Subjects who have failed low-dose levetiracetam monotherapy are randomized to high dose levetiracetam or adjunctive therapy with lacosamide. Enrollment is 75% complete.


Autonomic Biomarkers of seizures to assess risk for sudden death in epilepsy patients (SUDEP)
These investigators are working with Rosalind Picard, an M.I.T. researcher to test electrodermal sensors that detect autonomic changes in the Epilepsy Monitoring Unit (EMU) as potential risk factors for children and adults at risk for SUDEP. Use of these sensors are now being extended into the outpatient setting.

Respiratory changes before, during, and after seizures
A clinical study investigating respiratory changes which may be associated with risk for SUDEP, in adults with epilepsy at BWH and in children with epilepsy at Children’s Hospital Boston.

Medical Simulation of sentinel events from the Epilepsy Monitoring Unit: Validation of a team training curriculum
The goal of this research study is to improve patient safety in the Epilepsy Monitoring Unit (EMU) by enhancing the seizure education of the neurology residents. Specific aims are 1) to measure the efficacy of a simulated curriculum in improving resident’s knowledge and attitudes in safely managing acute events in an EMU, and 2) to measure the inter-rater reliability of a safe practice procedural checklist to evaluate neurology resident and nurse team performance skills during a simulated EMU safety curriculum.

Epilepsy Surgery/Translational research

Dr. Jong Woo Lee and others collaborate with Dr. Syd Cash at MGH using microelectrodes to study the basic physiology of seizures from cortical neurons on our phase II epilepsy cases.

Retrospective study on the outcome of epilepsy surgery at Brigham and Women’s Hospital, lead by Ellen Bubrick, MD.


Neuroanatomical correlates of epileptogenicity in Alzheimer's disease (AD)
To determine structural differences of cortical architecture of AD patients with epilepsy in comparison to AD patients without epilepsy, by MRI morphometry. To calculate differences of functional networks of AD patients with epilepsy as assessed by resting BOLD MRI scans.

ICU EEG Monitoring

Critical Care EEG monitoring Research Consortium Database
BWH Role: Dr. Jong Woo Lee is sire-PI and co-investigator.

Evaluation of an etiologic diagnostic tool for the management of status epilepticus
The objective is to test the yield of a clinical tool to identify the etiology of status epilepticus.
Sponsor: Switzerland federal government. Begins July 1, 2013 – June 30, 2014.
BWH Role: Dr. Vincent Alvarez, visiting research fellow, will be Principal Investigator.


Psychogenic non-epileptic seizures (PNES): Clinical characterization and predictors of outcome
An existing barrier to care for patients with PNES is the lack of adequate multidisciplinary care involving neurologists, psychiatrists, and psychologists. We propose to identify characteristics of the populations of post-monitored PNES patients to determine predictors of adherence, and clinical improvement.

Functional and structural biomarkers of psychogenic non-epileptic seizures (PNES)
To examine frontolimbic functional activation patterns and connectivity differences in patients with PNES compared to healthy control subjects; To examine interactions between right parietal-temporal and premotor regions as a function of dissociation in patients with PNES; To examine frontolimbic, right parietal-temporal, and premotor volumetric differences in patients with PNES compared to healthy control subjects.
BWH Role: Dr. David Perez, Neurology-Psychiatry resident, Principal Investigator.

Disrupted sleep after a seizure and its impact on Memory Consolidation
The objective of this study is to look at the effect of daytime or nocturnal complex partial seizures on sleep dependent memory consolidation in patients admitted to the EMU.
BWH role: Dr. Ellen Bubrick & Dr. Rani Sarkis (Epilepsy fellow) are multi-Principal Investigators

Neuropsychological outcomes in refractory idiopathic generalized epilepsy (IGE)
Comparison of patients with IGE and temporal lobe epilepsy on neuropsychometric measures
BWH Role: Drs. Barbara Dworetzky is Principal-Investigator; Drs. Sarkis and Pietras are co-Investigators.


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