Phase 4
N=22
Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study
Lennox-Gastaut Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02731300 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Number of Seizure After Treatment by tDCS — 80.67; 93.43; 35.53; 93.14 seizures — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tDCS (Device)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Khon Kaen University
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seizure After Treatment by tDCS |
80.67; 93.43; 35.53; 93.14 | <0.05 sig |
| SECONDARY Number of Epileptic Discharge After Treatment by tDCS |
640.13; 800.86; 585.33; 831.43 | <0.05 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02731300). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.