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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through 4 years post-implant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ implant through 4 years post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant through 4 years post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness: Blinded evaluation period (BEP) responder rate
Safety: Annual device-related serious adverse event (SADE) rate
Secondary outcome measures
Safety: Post-op SAE rate
Other outcome measures
Affective status
Caregiver burden
Cognition
+5 moreTrial 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
1,340 Previous Clinical Trials
649,335 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
4,150 Patients Enrolled for Lennox Gastaut Syndrome
University of FloridaOTHER
1,341 Previous Clinical Trials
715,643 Total Patients Enrolled
NeuroPaceLead Sponsor
10 Previous Clinical Trials
1,475 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My epilepsy doesn't respond well to at least 2 medications without severe side effects.I have been on the same seizure medication for the last 2 months and can stay on it during the study.I have not had any severe mental health issues or suicidal thoughts in the last 6 months.I can attend all required study appointments.I am currently taking blood thinners.I have had 5 or more drop seizures per month in the last 2 months.You currently have a specific type of implanted device in your body for neurostimulation.I have had epilepsy surgery within the last 3 months or earlier.I can keep a seizure log by myself or with help.I was diagnosed with non-epileptic seizures in the last year.I am not on a special diet for epilepsy, or if I am, it has been stable for 2 months and I can maintain it during the study.My seizures do not originate from a specific area of my brain.I am at least 15 years old for the first group, or at least 12 for the second.I have been on a stable seizure medication plan for 2 months and can keep it the same during the study.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.I am a man, or if a woman, I cannot become pregnant or am using reliable birth control.I have had a severe seizure without a clear cause in the last year.I am at least 15 years old for the first group, or at least 12 for the second.The results of a certain type of brain wave test show patterns that are associated with a specific type of epilepsy called Lennox-Gastaut Syndrome.You had at least 5 severe seizures per month in the 2 months before joining the study. A severe seizure causes the whole body to suddenly go limp or stiff and can make you fall or get hurt.
Research Study Groups:
This trial has the following groups:- Group 1: Condition A
- Group 2: Condition B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people will be included in this experiment?
"That is correct. The information available on clinicaltrials.gov shows that this particular trial is looking for patients right now. This specific study was first posted on October 4th, 2020 and updated just recently on the 12th of October. They are admitting a total of 20 patients across 6 locations in different parts of the country."
Answered by AI
At how many hospitals or research centers is this trial being conducted?
"There are 6 recruitment sites for this trial, which are situated in Atlanta, Boston, San Francisco and 3 additional cities. If you want to make participation easier on yourself, it would be best to choose the clinical site closest to your location."
Answered by AI
Are investigators still enrolling patients for this research?
"Yes, this study is still recruiting patients according to the latest update on clinicaltrials.gov from October 12th, 2022. The trial was initially posted on October 4th of the same year."
Answered by AI
What are the risks and side effects associated with Condition A?
"While there is some evidence that Condition A is safe, it is only from preliminary Phase 2 trials. There is currently no data supporting efficacy for this medication."
Answered by AI
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