Transcranial Magnetic Stimulation for Epilepsy (TMS)
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|ClinicalTrials.gov Identifier: NCT02757547|
Recruitment Status : Terminated (Business decision to discontinue development of this investigational device.)
First Posted : May 2, 2016
Results First Posted : August 20, 2019
Last Update Posted : July 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Device: Transcranial magnetic stimulation - Placebo Arm Device: Transcranial magnetic stimulation - Active Arm||Not Applicable|
Investigators propose a safety and feasibility trial for treating epilepsy (Transcranial Magnetic Stimulation for Epilepsy. Principal Investigator: Robert Fisher, MD, PhD, Stanford University). In this approach, the cortical source of epileptic discharges is first localized with dense array electroencephalography (256-channel dEEG). This localization is then registered with neuronavigator software to allow precise targeting with slow (0. 5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) with the STM9000. The purpose in the feasibility study is to introduce Long Term Depression (LTD) of the seizure onset zone in order to reduce epileptiform discharges. The goal in the future pivotal trial will be to extend this approach to suppress seizures. The funds for this trial are provided by Stanford University. A loan of dEEG equipment and consulting are provided by Electrical Geodesics, Inc. (EGI). EGI seeks FDA's approval for this trial. EGI is the manufacturer of the dEEG system (GES 400) and the US distributor of the EB Neuro STM9000 rTMS system (manufactured in Italy by EB Neuro, S.p.A.).
The eventual goal will be a pivotal trial for a de novo 510k for dEEG-guided rTMS for suppressing epileptic seizures. The more limited goal of suppressing epileptic discharges (spikes) will allow careful evaluation of safety while demonstrating feasibility of the therapeutic action. In preparing this request, the investigators have studied the guidance on the special controls described for rTMS in the FDA Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems, Document issued on: July 26, 2011. In addition, because patients with epilepsy are at particular risk of seizures that may be induced or exacerbated by rTMS, investigators also address the unique risks of this population, the existing evidence on safety and efficacy of rTMS treatment of the epileptic focus, and the mitigation the investigators propose to minimize the risks.
EGI has received an IDE for a safety and feasibility trial for treating epileptic discharges with a different method and device, the Geodesic Transcranial Electrical Neuromodulation (GTEN 100) system. The primary difference in the present proposal is the use of rTMS (instead of the GTEN 100) to induce long term depression and thus suppression of the cortical excitability at the epileptic focus. Dr. Robert Fisher, the Principal Investigator on this project, is EGI's unpaid consultant. Dr. Fisher has received an IRB approval at Stanford University Hospital for the larger study with this title for 10 patients with dEEG-guided rTMS treatment of focal epilepsy with the GES 400 and STM9000. The present trial is a safety and feasibility study with 10 patients that will be conducted with an informed consent form that is now specific to this safety and feasibility study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Registered Electrical Sources for Effective TMS Treatment of Epilepsy|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||November 15, 2017|
Placebo Comparator: Transcranial magnetic stimulation - Placebo Arm
A placebo TMS coil is used.
Device: Transcranial magnetic stimulation - Placebo Arm
Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.
Active Comparator: Transcranial magnetic stimulation - Active Arm
An active TMS coil is used.
Device: Transcranial magnetic stimulation - Active Arm
Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.
Other Name: STM9000 Transcranial Magnetic Stimulator
- Suppression of Seizure Frequency [ Time Frame: Placebo compared to Active ]The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757547
|Principal Investigator:||Robert S Fisher, Ph.D.||Stanford University|