Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Beth Israel Lahey Health

Status: Completed

Conditions: Epilepsy, Temporal Lobe

Treatments: Device: High-frequency repetitive transcranial magnetic stimulation; Device: Low-frequency repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02339376

2014P000216

Details and patient eligibility

About

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).

Enrollment: 5 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

5 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Device: Low-frequency repetitive transcranial magnetic stimulation

Group 2

Experimental group

Description:

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

Treatment:

Device: High-frequency repetitive transcranial magnetic stimulation

Group 3

Sham Comparator group

Description:

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

Treatment:

Device: Sham repetitive transcranial magnetic stimulation