Safety and Effectiveness of Biomarker Targeted Stimulation in Epilepsy: BTSEE (Biomarker Targeted Stimulation for Epileptiform Events)

What is the goal of the study?

BTS is an adjunctive therapy in reducing the frequency of disabling focal onset seizures in children 7 to 17 years of age that are refractory to two or more antiepileptic medications. The primary objective of the study is to evaluate the safety of the BTS System and associated procedures in patients with medically refractory epilepsy. The primary safety evaluation endpoint will be an assessment of adverse events through 7 months post-implant. The secondary objectives of the study are to evaluate the long-term safety and clinical effectiveness of the BTS System and associated procedures in patients with medically refractory epilepsy. The secondary safety evaluation endpoints will be an assessment of adverse events through 12 and 24 months post-implant. Primary effectivensss endpoint will be the comparison of disabling seizure frequency for the interval of 4 to 7 months post-implant compared to both baseline and legacy diary data, if available. Secondary effectiveness endpoints will be disabling seizure frequency comparisons through 12 and 24 months post-implant. Clinical effectiveness will be evaluated using patient reported outcomes (PRO).

Who can participate in the study?

Please contact the study team listed below to learn more.

Study Team:

• PI (Study Doctor): Hannah Goldstein
• Study Team Member: Deborah Grenard, [email protected]