Trial Outcomes & Findings for Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study (NCT NCT02731300)
NCT ID: NCT02731300
Last Updated: 2016-06-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
Baseline, 4 Weeks
Results posted on
2016-06-29
Participant Flow
Study participants were recruited via advertisement at the pediatric outpatient department, Srinagarind hospital, Faculty of Medicine, Khon Kaen University, Thailand. A total of 22 patients with Lennox-Gastaut Syndrome (LGS) were enrolled between August 2010 and December 2013
All patients were assigned to record sizure frequency prior to start the protocol
Participant milestones
| Measure |
Active tDCS
2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Sham tDCS
0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
7
|
|
Overall Study
COMPLETED
|
15
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study
Baseline characteristics by cohort
| Measure |
Active tDCS
n=15 Participants
2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Sham tDCS
n=7 Participants
0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.67 years
STANDARD_DEVIATION 1.54 • n=5 Participants
|
6.29 years
STANDARD_DEVIATION 1.98 • n=7 Participants
|
6.55 years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Etiologies of epilepsy
Idiopathic
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Etiologies of epilepsy
Infantile spasm
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Etiologies of epilepsy
Neonatal hypoglycemia
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Etiologies of epilepsy
Preterm with severe birth asphyxia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Etiologies of epilepsy
Preterm with history of intercerebral hemorrhage
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Baseline seizure frequency per day
|
80.67 seizures per day
STANDARD_DEVIATION 54.43 • n=5 Participants
|
93.43 seizures per day
STANDARD_DEVIATION 59.94 • n=7 Participants
|
84.73 seizures per day
STANDARD_DEVIATION 55.13 • n=5 Participants
|
|
Baseline epileptic discharges per 30 minutes
|
640.13 epileptic discharges/30 mins
STANDARD_DEVIATION 263.30 • n=5 Participants
|
800.86 epileptic discharges/30 mins
STANDARD_DEVIATION 374.62 • n=7 Participants
|
691.27 epileptic discharges/30 mins
STANDARD_DEVIATION 303.62 • n=5 Participants
|
|
Age at onset of seizures
|
2.32 years
STANDARD_DEVIATION 2.39 • n=5 Participants
|
1.58 years
STANDARD_DEVIATION 1.70 • n=7 Participants
|
2.08 years
STANDARD_DEVIATION 2.18 • n=5 Participants
|
|
Number of antiepileptic drugs used
3 drugs
|
9 participants
n=5 Participants
|
3 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Number of antiepileptic drugs used
4 drugs
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of antiepileptic drugs used
5 drugs
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 WeeksOutcome measures
| Measure |
Active tDCS
n=15 Participants
2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Sham tDCS
n=7 Participants
0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
|---|---|---|
|
Number of Seizure After Treatment by tDCS
Week4
|
35.53 seizures
Standard Deviation 15.29
|
93.14 seizures
Standard Deviation 61.15
|
|
Number of Seizure After Treatment by tDCS
Baseline
|
80.67 seizures
Standard Deviation 54.43
|
93.43 seizures
Standard Deviation 59.95
|
SECONDARY outcome
Timeframe: Baseline, 4 WeeksOutcome measures
| Measure |
Active tDCS
n=15 Participants
2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Sham tDCS
n=7 Participants
0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
|---|---|---|
|
Number of Epileptic Discharge After Treatment by tDCS
Baseline
|
640.13 epileptic discharges/30 mins
Standard Deviation 263.30
|
800.86 epileptic discharges/30 mins
Standard Deviation 374.62
|
|
Number of Epileptic Discharge After Treatment by tDCS
Week4
|
585.33 epileptic discharges/30 mins
Standard Deviation 253.25
|
831.43 epileptic discharges/30 mins
Standard Deviation 392.22
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=15 participants at risk
2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
Sham tDCS
n=7 participants at risk
0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
superficial skin burn
|
6.7%
1/15 • Number of events 1
|
0.00%
0/7
|
Additional Information
Paradee Auvichayapat
Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.
Phone: 66896222624
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place