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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor:
Collaborators:
Massachusetts General Hospital
University Hospital Freiburg
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
DANIEL SAN JUAN ORTA, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier:
NCT01763294
First received: January 2, 2013
Last updated: January 5, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Refractory Epilepsy
Device: Nicolet Endeavor CR: 30min
Device: Nicolet Endeavor CR: 60min
Device: Nicolet Endeavor CR: 30min for 3 days
Device: Nicolet Endeavor CR: 30min for 5 days
Device: Nicolet Endeavor CR: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy

Resource links provided by NLM:


Further study details as provided by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:

Primary Outcome Measures:
  • Number of seizures [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The number of the seizures monthly for 2 months


Secondary Outcome Measures:
  • Frequency of epileptiform discharges [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The frequency of the epileptiform discharges on EEGs evaluate at the baseline, after therapy, 1 and 2 months.

  • Amplitude of epileptiform discharges [ Time Frame: 2 monts ] [ Designated as safety issue: No ]
    Amplitude of the epileptiform discharges on EEGs evaluate at the baseline, after therapy, 1 and 2 months.


Other Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Adverse effects reported by the patient during the therapy and the follow-up dates for 1 and 2 months.


Estimated Enrollment: 45
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicolet Endeavor CR: 30min
Apply 1 session of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system.
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.
Other Name: tdcs
Active Comparator: Nicolet Endeavor CR: 60min
Apply 1 session of 2 milliampere intensity for 60 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system.
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.
Other Name: tdcs
Active Comparator: Nicolet Endeavor CR: 30min for 3 days
Apply 3 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system.
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.
Other Name: tdcs
Active Comparator: Nicolet Endeavor CR: 30min for 5 days
Apply 5 sessions of 2 milliampere intensity for 30 minutes. The stimulation mode will be continuous with frequency of 3 Hz. The site of application depends on the basal EEG findings based on the international 10/20 system.
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.
Other Name: tdcs
Placebo Comparator: 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.
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • any gender
  • age ≥ 15 and <65 years
  • Refractory epilepsy characterized by 3 or more seizures by month and the right use of 2 or more antiepileptic drugs during the last 12 months
  • Not eligible for surgery treatment
  • Right attachment to the antiepileptic treatment established at least 12 months before the date of inclusion
  • Multifocal epilepsy defined as 2 or more lobar regions affected with epileptic activity

Exclusion Criteria:

  • Patients with pseudoseizures
  • Previous craniotomy
  • Active local infection of the skull
  • Informed consent not signed
  • Patients with generalized idiopathic epilepsy or focal idiopathic epilepsy
  • Patients in stupor or coma
  • Patients in lactation or pregnancy
  • Patients with chronic degenerative diseases of the nervous system
  • Patients with exacerbated chronic degenerative diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763294

Contacts
Contact: Daniel San-Juan, MD 525556063822 ext 2527 pegaso31@yahoo.com

Locations
Mexico
Instituto Nacional de Neurología y Neurocirugía Recruiting
Mexico City, DF, Mexico, 14269
Contact: Daniel San-Juan, MD    525556063822 ext 2527    pegaso31@yahoo.com   
Principal Investigator: Daniel San-Juan, MD         
Sponsors and Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Massachusetts General Hospital
University Hospital Freiburg
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Daniel San-juan, MD Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
  More Information

Publications:
Responsible Party: DANIEL SAN JUAN ORTA, Principal Investigator, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
ClinicalTrials.gov Identifier: NCT01763294     History of Changes
Other Study ID Numbers: 04/10
Study First Received: January 2, 2013
Last Updated: January 5, 2013
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez:
multifocal refractory epilepsy
tDCS
neurostimulation
seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 21, 2014