RNS System for Lennox-Gastaut Syndrome

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byMartha Morrell, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NeuroPace

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for individuals aged 12 or older with Lennox Gastaut Syndrome (LGS) who have frequent generalized seizures and haven't responded well to at least two antiseizure medications. They should not be on certain epilepsy diets, have a stable medication regimen, and can't be using other electrical brain stimulation devices. Women of childbearing age must use reliable contraception.

Inclusion Criteria

Your brain wave test shows patterns linked to a condition called Lennox-Gastaut syndrome.

My epilepsy doesn't respond well to at least 2 medications without severe side effects.

My seizures do not originate from a specific area of my brain.

+15 more

Exclusion Criteria

I have not had any severe mental health issues or suicidal thoughts in the last 6 months.

Participant is pregnant

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

+9 more

Participant Groups

The study tests the RNS System's safety and effectiveness as an additional treatment for reducing seizure frequency in LGS patients. It aims to gather initial data to help design a larger pivotal study that could extend the device's approved uses.

2Treatment groups

Active Control

Group I: Condition AActive Control1 Intervention

high-frequency short bursts (HFSB: 100 Hz, 160 µs pulse width, 200 msec burst)

Group II: Condition BActive Control1 Intervention

low-frequency long bursts (LFLB: 5 Hz, 160 µs pulse width, 5 sec burst)