Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Beth Israel Deaconess Medical Center5 enrolled

Overview

The overall goal of this study is to open up the promising treatment of repetitive transcranial magnetic stimulation (rTMS), which has been shown to be effective against seizures in patients with surface neocortical foci, to a much larger population of patients with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are not currently considered good rTMS candidates. The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients with deep seizure foci by targeting its usage to accessible cortical partner regions. In this study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to perform a randomized controlled assessment of repetitive transcranial magnetic stimulation protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The methods used in this study will include magnetic resonance imaging (MRI) of the brain, electroencephalography (EEG), and transcranial magnetic stimulation (TMS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Epilepsy, Temporal Lobe

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of mesial temporal lobe epilepsy based on the combination of clinical semiology, neuroimaging findings, and electroencephalogram results. * At least 1 seizure with loss of awareness per 4-week period, on average, despite the use of antiepileptic drugs Exclusion Criteria: * Prior brain surgery or exposure to transcranial magnetic stimulation * Rapidly progressive brain lesions * Inability to tolerate MRI or TMS * Specific MRI or TMS contraindication as set forth in standard protocols of our institution

Outcomes

Primary Outcomes

Self-reported Seizure Frequency

The primary outcome measure will be the self-reported frequency of seizures with loss of awareness, as recorded by participants in written seizure diaries to be provided to investigators at the end of the 12-week assessment period beginning with the initial day of intervention. This seizure frequency will be expressed as the number of days on which seizures with loss of awareness occurred per 4-week interval during the assessment period.

Time frame: 12 weeks