RNS System Clinical Research

Inclusion criteria
Participants in the study must be between 18 and 70 years of age and meet the following requirements:

Have disabling motor simple partial seizures, and/or complex partial seizures, and/or secondarily generalized seizures.
Have reported an average of three or more disabling seizures per 28 days over the previous three 28-day periods, with no less than two seizures in a one-month period.
Have failed treatment with at least two antiepileptic medications.

The criteria listed above are not the only eligibility criteria. Only a clinical research study staff member can determine your eligibility for this clinical research study.

All study participants will keep a seizure diary. Participants are eligible for implantation once the seizure diary shows an average of three or more seizures per month over three consecutive months with no fewer than two seizures in any one month. Participants may then undergo the implantation procedure.

For the first month after implantation, all participants will have responsive stimulation turned OFF. After the first month, participants will be randomly selected to be in one of two groups, one of which will have responsive stimulation turned ON, and the other group will continue to have responsive stimulation turned OFF. Participants will not know which group they are in.

Approximately 20 weeks following the implant procedure all participants will be given the option to have responsive stimulation ON, regardless of which group they were initially assigned to.

Participants will be required to keep a seizure diary. Participants will have regular office visits to see the study physicians for approximately one year and will then be followed less frequently for another year.

Participants will not have to pay for any medical care they get from the study except for any co-payments or other cost-sharing payments required by the participant’s health insurance plan.

To help cover out-of-pocket expenses, participants will be paid $25.00 for each required study visit. Additional financial assistance may be available to eligible participants through foundations and other third party organizations.