A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a prospective interventional clinical study. All enrolled patients have multifocal
      and refractory epilepsy that voluntarily will accept to participate in the study signing a
      consent informed form. All patients are from the epilepsy clinic our Institute that meet the
      criteria. All patients will be randomized and divided in 5 groups (45 patients); placebo
      group, active group of one session 30 minutes, active group of one session of 60 minutes,
      active group of 30 minutes for 3 consecutively days and 30 minutes for 5 consecutively days.
      After the selection, the patients will record their EEG of 30 min in order to register the
      basal epileptic activity and determine the most epileptic area, where the intervention will
      be applied. Then, an EEG will be realized after the intervention, one month after and two
      months after.

      The equipment used to apply the therapy is approved for medical use in our country. The
      equipment is Nicolet, Endeavor used at low amplitude for direct electrical nervous
      stimulation mode. The intensity to apply will be 2 milliampere. The stimulation mode is
      continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings,
      nevertheless, it is ruled by the international EEG 10/20 system.

      The cathodal electrode is applies with disposable needle of 12 mm long and 0.5 mm wide, while
      the anodal electrode is applied with conventional cup electrodes with a 2mm hole in the
      center an a recording surface of silver chloride /silver. After the intervention the patient
      is asked about any adverse effect form the therapy application and the EEG is realized as the
      investigators described before. The patient will receive a follow up dates at one and two
      months. The patient must make a calendar with the frequency of seizures and must not change
      the actual medication.

      Placebo. This group receives the same procedures just that in this case the machine produces
      a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.

      The investigators will record the frequency of the seizures and analysis of the epileptiform
      activity in the EEGs in the baseline, after therapy, 1 month and 2 months of follow-up. As
      well the safety profile of the tDCS.
    

Intervention name(s): Nicolet Endeavor CR: 30min; Nicolet Endeavor CR: 60min; Nicolet Endeavor CR: 30min for 3 days; Nicolet Endeavor CR: 30min for 5 days; Nicolet Endeavor CR: Placebo
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): 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.; 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.; 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.; 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.; 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.
Other intervention name(s): tdcs; tdcs; tdcs; tdcs; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multifocal refractory epilepsy; tDCS; neurostimulation; seizures