Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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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:
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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
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Outcome Measures
Primary Outcome Measures
- Seizure frequency [12 weeks]
Secondary Outcome Measures
- Interictal epileptiform discharge frequency on electroencephalogram [at 12 week follow-up]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of mesial temporal lobe epilepsy based on the combination of clinical semiology, neuroimaging findings, and electroencephalogram results.
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At least 1 seizure with loss of awareness per 4-week period, on average, despite the use of antiepileptic drugs
Exclusion Criteria:
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Prior brain surgery or exposure to transcranial magnetic stimulation
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Rapidly progressive brain lesions
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Inability to tolerate MRI or TMS
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Specific MRI or TMS contraindication as set forth in standard protocols of our institution
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 2014P000216