Clinical Trials

Inclusion Criteria:

* Participants ≥ 18 years of age.
* Participants with Drug Resistance Epilepsy as defined by the ILAE5.
* Participants undergoing bilateral implantation of DBS leads into the anterior nucleus of the thalamus.
* Adequate organ function as assessed by the following laboratory values within 3 weeks prior to admission to the study:
* Serum creatinine and urea \< 2 times the upper limit of normal;
* ALT, AST and alkaline phosphatase \< 3 times the upper limit of normal, and bilirubin \< 2.5 mg/dL;
* Prothrombin time ≤ 1.5 times upper limit of normal;
* INR and PTT ≤ 1.5 times the upper limit of normal;
* Hemoglobin ≥ 9 g/dL;
* Platelets ≥ 100 x 10\^9/L;
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L.
* Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol.
* Patient is a candidate for ANT DBS based on the following criteria established by the American Society for Stereotactic and Functional Neurosurgeons:
* Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, with or without generalization;
* Failure to adequately control seizures after two (or more) appropriate and adequately-dosed anti-seizure medications;
* Either partial-onset seizures with a localized onset in a region not amenable to resection or following failed resective surgery or focal-onset seizures with distributed or unclear onset zone.

Exclusion Criteria:

* Patients who have undergone a prior intracranial procedure for epilepsy.
* Patients with an intracranial tumor.
* Confirmed pregnancy.
* History of cancer not in remission for at least 5 years.
* History of diabetes, chronic renal failure, or other significant underlying medical or ----immunosuppressive conditions.
* History of drug or alcohol abuse.
* Subjects allergic to any component of the investigational product.
* Subjects \> 75 years of age.
* Cognitively impaired adults.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/02/2024. Questions regarding updates should be directed to the study team contact.