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Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study

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ClinicalTrials.gov Identifier: NCT02731300
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : June 29, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Paradee Auvichayapat, Khon Kaen University

Brief Summary:

Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous study of cathodal transcranial direct current stimulation (tDCS) in children with focal epilepsy showed significant reduction in epileptiform discharges. The investigator hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with pharmacologic treatment will be more effective for reducing seizure frequency in participants with LGS than pharmacologic treatment alone.

Material and Method:

Study participants were randomized to receive either:

  1. pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over M1 for 20 min or
  2. pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic discharges were performed before treatment and again immediately post-treatment and 1-, 2-, 3-, and 4-week follow-up.

Condition or disease Intervention/treatment Phase
Lennox-Gastaut Syndrome Device: tDCS Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome, A Pilot Study
Study Start Date : August 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active tDCS
2 mA of cathodal tDCS placed over M1 for 20 mins
Device: tDCS
brain stimulation by cathodal electrode at motor cortex

Sham Comparator: Sham tDCS
0 mA of sham tDCS placed over M1 for 20 mins
Device: tDCS
brain stimulation by cathodal electrode at motor cortex




Primary Outcome Measures :
  1. Number of Seizure After Treatment by tDCS [ Time Frame: Baseline, 4 Weeks ]

Secondary Outcome Measures :
  1. Number of Epileptic Discharge After Treatment by tDCS [ Time Frame: Baseline, 4 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of LGS
  • Failure of more than two first-line AEDs to control seizures
  • Average seizure frequency of more than one per month for 18 months and no more than three consecutive seizure-free months during that interval
  • Age between 6 and 15 years

Exclusion Criteria:

  • Drug addiction
  • Pregnancy
  • Skull defect
  • Other serious neurological diseases and change in dosage of antiepileptic drugs or use of herbal remedies and other alternative therapies.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paradee Auvichayapat, Head of Noninvasive Brain Stimulation Research Group of Thailand, Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand., Khon Kaen University
ClinicalTrials.gov Identifier: NCT02731300     History of Changes
Other Study ID Numbers: tDCSLennox
First Posted: April 7, 2016    Key Record Dates
Results First Posted: June 29, 2016
Last Update Posted: June 29, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paradee Auvichayapat, Khon Kaen University:
Transcranial direct current stimulation
Cathodal stimulation
Childhood Pharmacoresistant epilepsy
Lennox-Gastaut syndrome
Additional relevant MeSH terms:
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Lennox Gastaut Syndrome
Syndrome
Disease
Pathologic Processes
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn