Statistically significant6 improvements in:
- Naming (p<0.001)
- Verbal Learning (p<0.03)
- Visual Memory (p<0.03)
- Executive Function (p<0.001)
Safety outcomes from
prospective clinical trials
- No adverse cognitive effects6
- No chronic stimulation side effects7
- Rates of serious device-related adverse events comparable to that of deep brain stimulation for movement disorders8,9
*Combined trial outcomes include data from Feasibility, Pivotal (randomized, double-blind, controlled), and Long-Term Treatment (open label, prospective) Trials. Long-Term Treatment Trial was not powered to drive conclusions of clinical significance.
**Based on last observation carried forward analysis.
***Population includes 707 patients treated either as part of clinical trials or as part of clinical care following FDA approval.
1. Gwinn R, et al, AES Poster, 2017
2. TRE = Treatment Resistant Epilepsy
3. Ryvlin P, et al, Lancet Neurol, 2011
4. Dasheiff, RM, J Clin Neurophysiol, 1991
5. Devinsky O, et al, Epilepsia, 2018
6. Loring DW, et al, Epilepsia, 2015
7. Heck, CN, et al, Epilepsia, 2014
8. Morrell, MJ, et al, Epilepsia, 2011
9. Weber, PB, et al, Sterotact Funct Neurosurg, 2017