Daniel San-Juan1, Dulce Anabel Espinoza López2, Rafael Vázquez Gregorio2, Carlos Trenado3, Maricarmen Fernández-González Aragón2, León Morales-Quezada4, Axel Hernandez Ruiz5, Flavio Hernandez-González6, Alejandro Alcaraz-Guzmán7, David J Anschel8, Felipe Fregni9. 1. Clinical Neurophysiology Department, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez, Av. Insurgentes Sur 3877, Col. La Fama, Tlalpan, Ciudad de México 14269, Mexico; Dresden International University, Division of Health Care Sciences, Center for Clinical Research and Management Education, Freiberger Straße 37, 01067 Dresden, Germany. Electronic address: pegaso31@yahoo.com. 2. Clinical Neurophysiology Department, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez, Av. Insurgentes Sur 3877, Col. La Fama, Tlalpan, Ciudad de México 14269, Mexico. 3. Institute of Clinical Neuroscience and Medical Psychology, University Hospital Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany. 4. Laboratory of Neuromodulation, Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 125 Nashua Street, Boston, MA 02114, USA; Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Ave, Boston, MA 02215, USA. 5. Superior School of Medicine, National Polytechnic Institute, Av. Salvador Díaz Mirón esq. Plan de San Luís, Col. Casco de Santo Tomás, Miguel Hidalgo, Ciudad de México 11340, Mexico. 6. Superior School of Medicine of Autonomous University of Aguascalientes, Av. Universidad 940, Ciudad Universitaria, Aguascalientes, Aguascalientes 20131, Mexico. 7. Superior School of Medicine of University of Colima, Av. Universidad 333, Las víboras, Colima, Colima 28040, Mexico. 8. Comprehensive Epilepsy Center of Long Island, St. Charles Hospital, Port Jefferson, NY, USA. 9. Laboratory of Neuromodulation, Department of Physical Medicine & Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, 125 Nashua Street, Boston, MA 02114, USA.
Abstract
BACKGROUND:Transcranial direct current stimulation (tDCS) has been evaluated in medication refractory epilepsy patients. The results have been inconclusive and protocols have varied between studies. OBJECTIVE: To evaluate the safety and efficacy of two protocols of tDCS in adult patients with mesial temporal lobe epilepsy and hippocampal sclerosis (MTLE-HS). METHODS: This is a randomized placebo-controlled, double-blinded clinical trial, with 3 arms, 3 sessions, 5 sessions and placebo stimulation. Frequency of seizures (SZs), interictal epileptiform discharges (IEDs) and adverse effects (AEs) were registered before and after treatment, and at 30 and 60 days follow-up. Descriptive statistics, k-related samples, Friedman's test, and relative risk (RR) estimation were used for analysis. RESULTS: We included twenty-eight subjects (3d n = 12, 5d n = 8, placebo n = 8), 16/28 (57%) men, age 37.8(±10.9) years old. There was a significant reduction of the frequency of SZs at one (p = 0.001) and two (p = 0.0001) months following cathodal tDCS compared to baseline in the 3 arms (p = 0.0001). The mean reduction of SZ frequency at two months in both active groups was significantly higher than placebo (-48% vs. -6.25%, p < 0.008). At 3 days (-43.4% vs. -6.25%, p < 0.007) and 5 days (-54.6% vs. -6.25%, p < 0.010) individual groups showed a greater reduction of SZs. A significant IED reduction effect was found between baseline and immediately after interventions (p = 0.041) in all groups. Side effects were minor. CONCLUSIONS: Cathodal tDCS technique of 3 and 5 sessions decreased the frequency of SZs and IEDs (between baseline and immediately post-tDCS) in adult patients with MTLE-HS compared to placebo tDCS.
RCT Entities:
BACKGROUND: Transcranial direct current stimulation (tDCS) has been evaluated in medication refractory epilepsypatients. The results have been inconclusive and protocols have varied between studies. OBJECTIVE: To evaluate the safety and efficacy of two protocols of tDCS in adult patients with mesial temporal lobe epilepsy and hippocampal sclerosis (MTLE-HS). METHODS: This is a randomized placebo-controlled, double-blinded clinical trial, with 3 arms, 3 sessions, 5 sessions and placebo stimulation. Frequency of seizures (SZs), interictal epileptiform discharges (IEDs) and adverse effects (AEs) were registered before and after treatment, and at 30 and 60 days follow-up. Descriptive statistics, k-related samples, Friedman's test, and relative risk (RR) estimation were used for analysis. RESULTS: We included twenty-eight subjects (3d n = 12, 5d n = 8, placebo n = 8), 16/28 (57%) men, age 37.8(±10.9) years old. There was a significant reduction of the frequency of SZs at one (p = 0.001) and two (p = 0.0001) months following cathodal tDCS compared to baseline in the 3 arms (p = 0.0001). The mean reduction of SZ frequency at two months in both active groups was significantly higher than placebo (-48% vs. -6.25%, p < 0.008). At 3 days (-43.4% vs. -6.25%, p < 0.007) and 5 days (-54.6% vs. -6.25%, p < 0.010) individual groups showed a greater reduction of SZs. A significant IED reduction effect was found between baseline and immediately after interventions (p = 0.041) in all groups. Side effects were minor. CONCLUSIONS: Cathodal tDCS technique of 3 and 5 sessions decreased the frequency of SZs and IEDs (between baseline and immediately post-tDCS) in adult patients with MTLE-HS compared to placebo tDCS.
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