Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02339376
Collaborator
(none)
5
1
3
74.3
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Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Low-frequency repetitive transcranial magnetic stimulation
  • Device: High-frequency repetitive transcranial magnetic stimulation
  • Device: Sham repetitive transcranial magnetic stimulation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Mar 10, 2021
Actual Study Completion Date :
Mar 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

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
Other Names:
  • Nexstim eXimia TMS stimulator with neuronavigation
  • Experimental: Group 2

    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
    Other Names:
  • Nexstim eXimia TMS stimulator with neuronavigation
  • Sham Comparator: Group 3

    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

    Outcome Measures

    Primary Outcome Measures

    1. Seizure frequency [12 weeks]

    Secondary Outcome Measures

    1. Interictal epileptiform discharge frequency on electroencephalogram [at 12 week follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: Bernard S Chang, MD, MMSc, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bernard Chang, Associate Professor of Neurology, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT02339376
    Other Study ID Numbers:
    • 2014P000216
    First Posted:
    Jan 15, 2015
    Last Update Posted:
    Apr 30, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 30, 2021