Safety and efficacy of cathodal transcranial direct current stimulation in patients with Lennox Gastaut Syndrome: An open-label, prospective, single-center, single-blinded, pilot study.

Purpose: Lennox-Gastaut Syndrome (SLG) is a severe form of childhood refractory epilepsy. Only one pilot study has been conducted using cathodal transcranial direct current stimulation (c-tDCs; 2mAx30minx5days) in LGS with promising results (-99% seizure reduction at 5 days). Our aim was to explore and replicate the efficacy and safety of 10 daily sessions of c-tDCs in SLG.

Methods: We conducted a one-blinded, single-center pilot clinical study of c-tDCs (2mAx 30 min x 10 days), applied over the highest amplitude or frequent epileptiform interictal discharges areas using scalp EEG recordings without changes in their treatments. The tDCS device used was Enobio EEG® (Neuroelectrics, Barcelona, Spain). The primary outcome was based on the seizure frequency using seizure diaries before, during 10 days of treatment, and then on a 4 and 8 weeks of follow-up. The rate of adverse events was recorded as a secondary outcome. Descriptive statistics and Wilcoxon signed-rank test were used RESULTS: Twenty-four patients were enrolled. The mean age was 10.1 ± 5.8 years old and 75% male. All the patients had severe mental retardation and abnormal neurological examinations. A significant median percentual seizure frequency reduction was found: 68.12% (p = 0.05) at 1 week, 68.12% (p = 0.002) in the second week. We found no significant reduction at 1 and 2 months; mainly tonic and atonic seizures were reduced significantly at all times. Only mild self-limited side effects were recorded mainly itching and erythema in the application zone CONCLUSION: Ten sessions of c-tDCs in combination with pharmacologic treatment in LGS is safe and appears to reduce significatively tonic and atonic seizure frequency at 2 months of follow-up.