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NCT02339376 · ClinicalTrials.gov registry record · NA

Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

A NA study, sponsored by Beth Israel Deaconess Medical Center.

Completed
Registry status
NA
Development phase
5
Enrollment target

NCT02339376: Completed NA study, sponsored by Beth Israel Deaconess Medical Center.

NCT02339376 is a NA study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02339376, a NA study, has completed, sponsored by Beth Israel Deaconess Medical Center.

COMPLETED
Registry status
NA
Development phase
5 participants
Enrollment target

Study 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).

Primary Outcome

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.

Interventions

  • DEVICE Sham repetitive transcranial magnetic stimulation
  • DEVICE Low-frequency repetitive transcranial magnetic stimulation
  • DEVICE High-frequency repetitive transcranial magnetic stimulation

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2015-01
Est. Completion 2021-03-10
Phase NA

What the finished NCT02339376 record still lists

NCT02339376 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 3 interventions - of which Sham repetitive transcranial magnetic stimulation is the first listed.

NCT02339376 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02339376 about?

NCT02339376 is a clinical study titled "Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation". 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 (MT...

What is the current status of trial NCT02339376?

This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2015-01. Estimated completion is 2021-03-10.

What interventions are being tested in trial NCT02339376?

The interventions under investigation include: Sham repetitive transcranial magnetic stimulation (DEVICE), Low-frequency repetitive transcranial magnetic stimulation (DEVICE), High-frequency repetitive transcranial magnetic stimulation (DEVICE).

Who is sponsoring clinical trial NCT02339376?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02339376's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02339376, the US trial registry maintained by the National Library of Medicine. NCT02339376 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.