Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

NCT02339376 | Completed Results FDA Device

• 1 other identifier: 2014P000216
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Epilepsy, Temporal Lobe

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Group 3

SHAM COMPARATOR

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

Interventions

Low-frequency repetitive transcranial magnetic stimulation DEVICE

Also known as: Nexstim eXimia TMS stimulator with neuronavigation

Group 1

High-frequency repetitive transcranial magnetic stimulation DEVICE

Also known as: Nexstim eXimia TMS stimulator with neuronavigation

Group 2

Sham repetitive transcranial magnetic stimulation DEVICE

Group 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Epilepsy, Temporal Lobe

Interventions

Neuronavigation

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Investigative Techniques

Results Point of Contact

• Title: Bernard S. Chang, M.D.
• Organization: Beth Israel Deaconess Medical Center

bchang@bidmc.harvard.edu

617-632-8930

Study Officials

• Bernard S Chang, MD, MMSc

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 15, 2015
• Study Start: January 1, 2015
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Locations

US (1)