to find out if thalamic stimulation with NeuroPace RNS® System is safe
and effective (works well) as an additional treatment in reducing the
frequency of primarily generalized seizures in individuals 12 years of
age or older with drug resistant idiopathic generalized epilepsy (IGE).
Intervention: NeuroPace RNS® System implantation (50% chance) or sham implantation (50% chance).
Timeline: up to 14 in person visits over up to 2 years.
Purpose: to evaluate the safety and efficacy of a surgical cell therapy called NRTX-1001 in participants with drug resistant mesial temporal lobe epilepsy (MTLE). Additionally, to see if NRTX-1001 can reduce number of seizures.
Intervention: there are two different stages of this study, described below.If eligible, you would participate in one of the stages.
NRTX-1001 (66% chance) or sham surgery (33% chance)
Timeline: 13 visits over 24 months, then long-term follow up for 13 years (for both stages).
Key Eligibility Criteria: age: 18-65 years old, diagnosis: temporal lobe epilepsy, seizure frequency average 2 or more per 28 day period in the previous 6 months, has failed to achieve seizure control despite trials of at least 2 anti-seizure drugs