Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Study Overview
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Brief Summary
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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).

Official Title
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Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Conditions
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Epilepsy, Temporal Lobe

Intervention / Treatment
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* Device: Low-frequency repetitive transcranial magnetic stimulation
* Device: High-frequency repetitive transcranial magnetic stimulation
* Device: Sham repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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 | Device: Low-frequency repetitive transcranial magnetic stimulation<br> <br> * Other names: Nexstim eXimia TMS stimulator with neuronavigation;|
| Experimental: Group 2<br>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 | Device: High-frequency repetitive transcranial magnetic stimulation<br> <br> * Other names: Nexstim eXimia TMS stimulator with neuronavigation;|
| Sham Comparator: Group 3<br>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 | Device: Sham repetitive transcranial magnetic stimulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interictal epileptiform discharge frequency on electroencephalogram |  | at 12 week follow-up |