Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Not Applicable

Completed

• Conditions: Epilepsy, Temporal Lobe

• Registration Number: NCT02339376
• Lead Sponsor: Beth Israel Deaconess Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-08
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-15
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Results First Submitted: 2022-12-12
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Results First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States