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Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Primary Purpose

Epilepsy, Temporal Lobe

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-frequency repetitive transcranial magnetic stimulation
High-frequency repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy, Temporal Lobe

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Group 1

Group 2

Group 3

Arm 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

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

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

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Interictal epileptiform discharge frequency on electroencephalogram

Full Information

First Posted
January 8, 2015
Last Updated
April 28, 2021
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02339376
Brief Title
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Official Title
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Temporal Lobe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm 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
Arm Title
Group 2
Arm Type
Experimental
Arm 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
Arm Title
Group 3
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Low-frequency repetitive transcranial magnetic stimulation
Other Intervention Name(s)
Nexstim eXimia TMS stimulator with neuronavigation
Intervention Type
Device
Intervention Name(s)
High-frequency repetitive transcranial magnetic stimulation
Other Intervention Name(s)
Nexstim eXimia TMS stimulator with neuronavigation
Intervention Type
Device
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Seizure frequency
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Interictal epileptiform discharge frequency on electroencephalogram
Time Frame
at 12 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard S Chang, MD, MMSc
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

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