Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Epilepsy, Temporal Lobe Clinical Trial

Official title:

Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339376
• Other study ID #: 2014P000216
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 10, 2021

Study information

• Verified date: April 2021
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy, Temporal Lobe
• Seizures

Intervention

Device:
• Low-frequency repetitive transcranial magnetic stimulation

• High-frequency repetitive transcranial magnetic stimulation

• Sham repetitive transcranial magnetic stimulation

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency		12 weeks
Secondary	Interictal epileptiform discharge frequency on electroencephalogram		at 12 week follow-up