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RNS System for Lennox-Gastaut Syndrome

Phase 2
Recruiting
Led By Martha Morrell, MD
Research Sponsored by NeuroPace
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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's seizures are non-localized.
Must not have
Participant has a diagnosed unstable psychiatric disorder or any attempt or expressed intent of suicide over the preceding 6 months
Participant is taking any anticoagulants
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through 4 years post-implant
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study the feasibility and optimal design of a brain-responsive neurostimulation system to help reduce the frequency of generalized seizures in people with Lennox-Gastaut Syndrome who haven't responded to other medications.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, neurostimulation devices like the RNS System may cause discomfort at the implant site, headache, infection risk at implantation area, and possible interference with brain function depending on stimulation parameters.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My epilepsy doesn't respond well to at least 2 medications without severe side effects.
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My seizures do not originate from a specific area of my brain.
Select...
My epilepsy doesn't respond well to at least 2 medications without severe side effects.
Select...
I have had 5 or more drop seizures per month in the last 2 months.
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My seizures do not originate from a specific area of my brain.
Select...
I don't have a vagus nerve stimulator, or if I do, it's been off for 2 months and I can keep it off.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had any severe mental health issues or suicidal thoughts in the last 6 months.
Select...
I am currently taking blood thinners.
Select...
I was diagnosed with non-epileptic seizures in the last year.
Select...
I have had a severe seizure without a clear cause in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant through 4 years post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and implant through 4 years post-implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness: Blinded evaluation period (BEP) responder rate
Safety: Annual device-related serious adverse event (SADE) rate
Secondary study objectives
Safety: Post-op SAE rate
Other study objectives
Affective status
Caregiver burden
Cognition
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,376 Previous Clinical Trials
651,461 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
4,150 Patients Enrolled for Lennox Gastaut Syndrome
University of FloridaOTHER
1,397 Previous Clinical Trials
767,036 Total Patients Enrolled
NeuroPaceLead Sponsor
10 Previous Clinical Trials
1,475 Total Patients Enrolled

Media Library

Condition A Clinical Trial Eligibility Overview. Trial Name: NCT05339126 — Phase 2
Lennox Gastaut Syndrome Research Study Groups: Condition A, Condition B
Lennox Gastaut Syndrome Clinical Trial 2023: Condition A Highlights & Side Effects. Trial Name: NCT05339126 — Phase 2
Condition A 2023 Treatment Timeline for Medical Study. Trial Name: NCT05339126 — Phase 2
~10 spots leftby May 2026
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