Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Not Applicable

Completed

Interventions: Device: Sham repetitive transcranial magnetic stimulation
Device: Low-frequency repetitive transcranial magnetic stimulation
Device: High-frequency repetitive transcranial magnetic stimulation

Brief Summary: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group 3	Sham repetitive transcranial magnetic stimulation	Sham repetitive transcranial magnetic stimulation: use of a specially fabricated coil that provides no magnetic stimulation but has a similar appearance and creates an auditory artifact that mimics TMS
Group 1	Low-frequency repetitive transcranial magnetic stimulation	Low-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 1-Hz continuous stimulation at 95% resting motor threshold, with one session each day over 10 consecutive weekdays
Group 2	High-frequency repetitive transcranial magnetic stimulation	High-frequency repetitive transcranial magnetic stimulation: 30-minute sessions of 10-Hz continuous stimulation at 110% resting motor threshold, with one session each day over 10 consecutive weekdays

Primary Outcome Measures

Name	Time	Method
Self-reported Seizure Frequency	12 weeks	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.

Secondary Outcome Measures