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

Lennox-Gastaut Syndrome Clinical Trial

Official title:

Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome, A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731300
• Other study ID #: tDCSLennox
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2016
• Last updated: April 6, 2016
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2016
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Description:

Participant recruitment and informed consent Study participants were recruited via advertisement at the pediatric outpatient department, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. The study procedures were described to any eligible participants who expressed an interest in participating in the study by a pediatric neurologist.

Criteria for LGS were defined according to the triad of:

1. polymorphic intractable seizures that are mainly tonic, atonic, and atypical absence seizures,

2. cognitive and behavioral abnormalities,

3. EEG with paroxysms of fast activity and slow (less than 2.5 Hz) generalized spike-wave discharges (GSWD) [21].

The diagnosis was confirmed by a pediatric neurologist using the thoroughly history taking, physical examination, EEG, and brain MRI.

Study inclusion criteria included:

1. diagnosis of LGS;

2. failure of more than two first-line antiepilepsy drug (AEDs) to control seizures;

3. average seizure frequency of more than one per month for 18 months and no more than three consecutive seizure-free months during that interval;

4. age between 6 and 15 years.

The exclusion criteria were (a) drug addiction, pregnancy, skull defect, and other serious neurological diseases; and (b) change in dosage of antiepileptic drugs or use of herbal remedies and other alternative therapies.

All participants' guardians gave their written informed consent. The study conformed to the declaration of Helsinki and was approved by the Ethics Committee of Khon Kaen University (Identifier number: Human Ethic (HE) 521232.

Experimental design

The current study was a randomized double-blind controlled trial performed over a total of 6 weeks consisting of:

1. a 1-week period of observation to assess the baseline seizure frequency,

2. a 5 consecutive days of 2 mA cathodal tDCS for 30 minutes, and

3. 4 weeks of follow-up.

Just before the treatment phase, study participants were randomized in a 2:1 ratio in blocks of four randomization to receive either (a) pharmacologic treatment plus active tDCS stimulation or (b) pharmacologic treatment plus sham tDCS stimulation for 5 days. Participants were asked to continue their routine anti-epileptic medication regimen throughout the duration of the 6-week trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lennox-Gastaut Syndrome
• Syndrome

Intervention

Device:
• tDCS
brain stimulation by cathodal electrode at motor cortex

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of seizure after treatment by tDCS		4 weeks	Yes
Secondary	Number of epileptic discharge after treatment by tDCS		4 weeks	Yes