NCT01763294

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

January 2, 2013

Last Update Submit

April 5, 2015

Conditions

Refractory Epilepsy

Keywords

multifocal refractory epilepsytDCSneurostimulationseizures

Outcome Measures

Primary Outcomes (1)

  • Number of seizures

    The number of the seizures monthly for 2 months

    2 months

Secondary Outcomes (2)

  • Frequency of epileptiform discharges

    2 months

  • Amplitude of epileptiform discharges

    2 monts

Other Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety

    2 months

Study Arms (5)

Nicolet Endeavor CR: 30min

ACTIVE COMPARATOR

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

Nicolet Endeavor CR: 60min

ACTIVE COMPARATOR

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

Nicolet Endeavor CR: 30min for 3 days

ACTIVE COMPARATOR

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

Nicolet Endeavor CR: 30min for 5 days

ACTIVE COMPARATOR

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

Nicolet Endeavor CR: Placebo

PLACEBO COMPARATOR

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

Interventions

Nicolet Endeavor CR: 30minDEVICE

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.

Also known as: tdcs
Nicolet Endeavor CR: 30min
Nicolet Endeavor CR: 60minDEVICE

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.

Also known as: tdcs
Nicolet Endeavor CR: 60min
Nicolet Endeavor CR: 30min for 3 daysDEVICE

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.

Also known as: tdcs
Nicolet Endeavor CR: 30min for 3 days
Nicolet Endeavor CR: 30min for 5 daysDEVICE

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.

Also known as: tdcs
Nicolet Endeavor CR: 30min for 5 days
Nicolet Endeavor CR: PlaceboDEVICE

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.

Also known as: placebo
Nicolet Endeavor CR: Placebo

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Multifocal epilepsy defined as 2 or more lobar regions affected with epileptic activity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico City, 14269, Mexico

Location

Related Publications (3)

  • San-Juan D, Calcaneo Jde D, Gonzalez-Aragon MF, Bermudez Maldonado L, Avellan AM, Argumosa EV, Fregni F. Transcranial direct current stimulation in adolescent and adult Rasmussen's encephalitis. Epilepsy Behav. 2011 Jan;20(1):126-31. doi: 10.1016/j.yebeh.2010.10.031. Epub 2010 Dec 17.

    PMID: 21167786RESULT

  • Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.

    PMID: 16499758RESULT

  • San-Juan D, Espinoza Lopez DA, Vazquez Gregorio R, Trenado C, Fernandez-Gonzalez Aragon M, Morales-Quezada L, Hernandez Ruiz A, Hernandez-Gonzalez F, Alcaraz-Guzman A, Anschel DJ, Fregni F. Transcranial Direct Current Stimulation in Mesial Temporal Lobe Epilepsy and Hippocampal Sclerosis. Brain Stimul. 2017 Jan-Feb;10(1):28-35. doi: 10.1016/j.brs.2016.08.013. Epub 2016 Aug 31.

    PMID: 27693237DERIVED

MeSH Terms

Conditions

Drug Resistant EpilepsySeizures

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Daniel San-juan, MD

    Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 8, 2013

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

April 1, 2015

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

ME(1)