RNS System LGS Feasibility Study

ID#: NCT05339126

Age: 15 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: October 01, 2022

End Date: June 01, 2026

Contact Information:
Tricia Cunningham
831-854-3585
Julie Harvey Park
650-279-8599
Summary: To generate preliminary safety and effectiveness data for brain-responsive neurostimulation of thalamocortical networks as an adjunctive therapy in reducing the frequency of generalized seizures in individuals 12 years of age or older with Lennox Gastaut Syndrome (LGS) who are refractory to antiseizure medications. The intent is to determine the feasibility and the optimal design of a subsequent pivotal study in order to expand the indication for use for the RNS System as a treatment for patients with medically intractable LGS.
Eligibility:

Inclusion Criteria:

- Participant is 15 years of age or older for first cohort; 12 years of age or older for second cohort. Note that age requirements for eligibility differ by cohort, as follows: the age limit for Cohort 1 is 15 years of age and above and the age limit for Cohort 2 may decrease to 12 years, pending a DSMB letter of recommendation, based on review of interim data analysis and concurrence with NINDS.

- Participant has medically intractable epilepsy defined as failure to achieve acceptable seizure control without unacceptable medication related side effects despite trials of 2 or more antiseizure medications.

- Participant had an average of ≥ 5 drop seizures per month in the 2 months preceding enrollment. A drop seizure is defined as an epileptic seizure (atonic, tonic, tonic-clonic, or myoclonic) involving the entire body, trunk, or head that leads or could lead to a fall, injury, or slumping in a chair.

- Participant's seizures are non-localized.

- Participant's scalp recorded EEG has features of LGS, such as multifocal spike, slow spike and wave discharges, and paroxysmal fast activity.

- Participant must (a) have a stable antiseizure medication (ASM) regimen for the 2 months preceding enrollment and (b) be willing to remain on the stable regimen, as medically able, through the Blinded Evaluation Period; rescue medication for acute seizure clusters are permitted. A stable ASM regimen is defined as no introduction or discontinuation of an ASM, and no change in an ASM dose of more than 25%.

- Participant is not on a therapeutic diet for epilepsy, or if participant is on a therapeutic diet for epilepsy must (a) have a stable diet for the 2 months preceding enrollment and (b) be willing to remain on the stable diet, as medically able, through the Blinded Evaluation Period.

- Participant does not have a vagus nerve stimulator (VNS), or if participant does have a VNS must (a) have had the VNS off for the 2 months preceding enrollment and (b) be willing to remain with the VNS off through the Blinded Evaluation Period.

- Participant is a male, or is a female of childbearing potential who is surgically sterile, 2 years postmenopausal, or practices a reliable method of contraception (hormonal, barrier method or abstention).

- Participant is willing to give informed consent (or assent, if a minor); if the participant assents or is not able to give informed consent, parent/legal guardian is willing to give informed consent.

- Participant is able to maintain a seizure log alone or with the assistance of a competent individual.

- Participant is able to attend study appointments in accordance with the study schedule.

Exclusion Criteria:

- Participant is participating in a therapeutic investigational drug or device study (including other RNS System studies).

- Participant is currently implanted with an electronic medical device that delivers electrical energy to the brain.

- Participant is currently implanted with an RNS Neurostimulator or NeuroPace Leads.

- Participant requires procedures that are contraindicated based on current RNS System labeling.

- Participant is pregnant.

- Participant has a diagnosed unstable psychiatric disorder or any attempt or expressed intent of suicide over the preceding 6 months.

- In the opinion of the investigator, the participant has a clinically significant or unstable medical condition [including alcohol, opioid, recreational cannabis (not for therapeutic purposes) or other drug use disorder] or a progressive central nervous system disease.

- Participant is taking any anticoagulants.

- In the opinion of the investigator, participant is an unsuitable candidate for this procedure.

- Participant has been diagnosed with psychogenic or non-epileptic seizures in the preceding year.

- Participant has experienced unprovoked status epilepticus in the preceding year.

- Participant has had therapeutic surgery to treat epilepsy in the preceding 3 months. Participants who have had epilepsy surgery more than 3 months prior to enrollment are eligible. Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).