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Neurostimulation with RNS System for Epilepsy (RESPONSE Trial)
N/A
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
Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
Subject is age 12 or older but will be less than age 18 (has not reached 18th birthday) at the time of implantation with the RNS System.
Must not have
Subject is taking chronic anticoagulants.
Subject has experienced unprovoked status epilepticus in the preceding year.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through 2 years post-implant
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a device that sends electrical pulses to the brain is safe and effective in treating people with epilepsy who haven't responded to other treatments.
Who is the study for?
This trial is for young individuals aged 12-17 with medically refractory partial onset epilepsy. They must have regular, countable seizures and not be pregnant or using certain medications. Participants need to commit to clinic visits, maintain a seizure diary, and have failed at least two anti-seizure drugs.
What is being tested?
The RNS System RESPONSE Study is testing the safety and effectiveness of the RNS System as an additional treatment for epilepsy in adolescents. The study involves surgical implantation of this neurostimulator device.
What are the potential side effects?
Potential side effects may include discomfort or complications from surgery, infection risk at the implant site, possible changes in mood or behavior due to neurological stimulation, and device-related issues like malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe seizures that affect my daily life.
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I am between 12 and 17 years old, not yet 18.
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I've had 3 or more disabling seizures per month for the last 2 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on long-term blood thinners.
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I have had a severe seizure without a clear cause in the last year.
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I have been diagnosed with seizures not caused by epilepsy.
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I have been diagnosed with generalized seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ implant through 2 years post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~implant through 2 years post-implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Responder rate at 12 months post implant
Short-term chronic serious adverse device effect (SADE) rate
Other study objectives
Affective status as measured by the Beck Depression Inventory
Device-related Serious Adverse Event (SADE) event rate
Event rate of Serious Adverse Events (SAEs) of particular relevance
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Evaluation Group (stimulation ON)Experimental Treatment1 Intervention
Group of participants that have an RNS System implanted and are being treated with responsive stimulation.
Find a Location
Who is running the clinical trial?
NeuroPaceLead Sponsor
10 Previous Clinical Trials
1,297 Total Patients Enrolled
8 Trials studying Epilepsy
1,211 Patients Enrolled for Epilepsy
Martha Morrell, MDPrincipal InvestigatorNeuroPace, Inc.
2 Previous Clinical Trials
122 Total Patients Enrolled
2 Trials studying Epilepsy
122 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a device in your brain that sends electrical energy.You have had medical tests that showed you have no more than two areas in your brain that can cause seizures.I or my caregiver can reliably count and describe my distinct seizures.I have been diagnosed with severe mental health issues like psychosis or major depression in the last year.I am on long-term blood thinners.My doctor thinks I can safely undergo a brain surgery.I have had a severe seizure without a clear cause in the last year.I have severe seizures that affect my daily life.I have tried at least two seizure medications without success.I can attend all required clinic appointments for the study.I have been diagnosed with seizures not caused by epilepsy.I am using a reliable method of birth control.I am between 12 and 17 years old, not yet 18.I have been diagnosed with generalized seizures.I've had 3 or more disabling seizures per month for the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Evaluation Group (stimulation ON)
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.