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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~implant through 2 years post-implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and implant through 2 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
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 more

Awards & 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

RNS System Clinical Trial Eligibility Overview. Trial Name: NCT04839601 — N/A
Epilepsy Research Study Groups: Evaluation Group (stimulation ON)
Epilepsy Clinical Trial 2023: RNS System Highlights & Side Effects. Trial Name: NCT04839601 — N/A
RNS System 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839601 — N/A
~64 spots leftby Jul 2026