Abstracts

Rationale: We designed a prospective, randomized, controlled, double-blinded study to evaluate the efficacy of Hip-DBS in patients with refractory TLE. Methods: Sixteen adult patients with refractory temporal lobe epilepsy were studied. Patient’s workup included medical history, interictal and ictal EEG, and high resolution 1.5T MRI. Patients were randomized on a 1:1 proportion to an active (stimulation on) or to a control (no stimulation) arm. After implantation, patients were allowed to recover for one month, which was followed by a one month titration (or sham) period. The six-months blinded phase started immediately afterwards. A post-operative MRI confirmed the electrode’s position in all patients. All patients received bipolar continuous stimulation. Stimulus duration was 300µsec and frequency was 130Hz; final intensity was 2V.  Patients were considered responders when they had at least 50% seizure frequency reduction. Results: All patients had focal impaired awareness seizures (FIAS,complex partial seizures), and 87% had focal aware seizures (FAS, simple partial seizures). Mean preoperative seizure frequency was 12,5±9.4 per month. MRI was normal in 2 patients, disclosed bilateral mesial temporal sclerosis (MTS) in 3, left MTS in 5, and right MTS in 6 patients (Table I). An insertional effect could be noted in both control and active patients. In the active group (n=8), 4 patients became seizure free; 7 out of 8 were considered responders and one was a non-responder. There was a significant difference regarding FIAS frequency between the 2 groups from the first month of full stimulation (p Conclusions: Hip-DBS was effective in significantly reducing the seizure frequency in patients with refractory temporal lobe epilepsy in the active group, as compared to the control group. Fifty-percent of the patients in the active group became seizure-free. The present study is the larger prospective, controlled, double-blinded one to evaluate the effects of Hip-DBS published so far. Funding: No funding.