A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy

Summary

There is a continuous necessity for the search of new alternatives for safe, affordable and effective noninvasive therapies for patients that are not eligible for focal resective or palliative surgery. The transcranial direct current stimulation (tDCS) therapy has demonstrated to be safe, noninvasive, simple and effective with promising results in case series, case reports and animals models for the treatment of intractable epilepsy. tDCS is a feasible and low cost method to modify cortical excitability in a non-invasive procedure. Its effects on cortical excitability seem to be similar to the effects induced by repetitive transcranial magnetic stimulation. The aim of this study is determine the safety and efficacy in the reduction of the number of seizures (\>50%) and epileptiform activity in patients with refractory and multifocal epilepsy after different protocols of tDCS compared with placebo.

Conditions

• Refractory Epilepsy

Interventions

DEVICE

Nicolet Endeavor CR: 30min

Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.

DEVICE

Nicolet Endeavor CR: 60min

Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.

DEVICE

Nicolet Endeavor CR: 30min for 3 days

Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.

DEVICE

Nicolet Endeavor CR: 30min for 5 days

Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.

DEVICE

Nicolet Endeavor CR: Placebo

The same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• University Hospital Freiburg

  collaborator OTHER

• Spaulding Rehabilitation Hospital

  collaborator OTHER

• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

  lead OTHER

Principal Investigators

• Daniel San-juan, MD · Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2012-12-31

Completion

2015-04-30

Countries

• Mexico

Study Locations