A Controlled Clinical Trial of Cathodal Transcranial Direct Current Stimulation in Patients With Refractory Epilepsy
NCT ID: NCT01763294
Last Updated: 2015-04-07
Study Results
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Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2012-02-29
2015-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
15 Years
65 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
University Hospital Freiburg
OTHER
Spaulding Rehabilitation Hospital
OTHER
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
OTHER
Responsible Party
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DANIEL SAN JUAN ORTA
Principal Investigator
Principal Investigators
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Daniel San-juan, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
Locations
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Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, Mexico
Countries
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References
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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.
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.
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.
Other Identifiers
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04/10
Identifier Type: -
Identifier Source: org_study_id
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