NCT02731300

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. 1.pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over M1 for 20 min or
  2. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Typical duration for phase_4

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

August 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 29, 2016

Completed
Last Updated

June 29, 2016

Status Verified

May 1, 2016

Enrollment Period

3.3 years

First QC Date

March 30, 2016

Results QC Date

April 8, 2016

Last Update Submit

May 20, 2016

Conditions

Lennox-Gastaut Syndrome

Keywords

Transcranial direct current stimulationCathodal stimulationChildhood Pharmacoresistant epilepsyLennox-Gastaut syndrome

Outcome Measures

Primary Outcomes (1)

  • Number of Seizure After Treatment by tDCS

    Baseline, 4 Weeks

Secondary Outcomes (1)

  • Number of Epileptic Discharge After Treatment by tDCS

    Baseline, 4 Weeks

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

2 mA of cathodal tDCS placed over M1 for 20 mins

Device: tDCS

Sham tDCS

SHAM COMPARATOR

0 mA of sham tDCS placed over M1 for 20 mins

Device: tDCS

Interventions

tDCSDEVICE

brain stimulation by cathodal electrode at motor cortex

Active tDCSSham tDCS

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Auvichayapat N, Sinsupan K, Tunkamnerdthai O, Auvichayapat P. Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome: A Pilot Study. Front Neurol. 2016 May 4;7:66. doi: 10.3389/fneur.2016.00066. eCollection 2016.

    PMID: 27199889DERIVED

MeSH Terms

Conditions

Lennox Gastaut Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epileptic SyndromesEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Limitations and Caveats

1. The investigators could not ensure that the stimulation electrode was directly over the primary motor cortex. 2. The sample size was small.

Results Point of Contact

Title
Paradee Auvichayapat
Organization
Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.
aparad@kku.ac.th
66896222624

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Noninvasive Brain Stimulation Research Group of Thailand, Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 7, 2016

Study Start

August 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 29, 2016

Results First Posted

June 29, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share