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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up implant through 2 years post-implant
Awards & highlights

RESPONSE Trial 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.Check my eligibility
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.See study design
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.

RESPONSE Trial 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.

RESPONSE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Responder rate at 12 months post implant
Short-term chronic serious adverse device effect (SADE) rate
Other outcome measures
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

RESPONSE 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
1,299 Total Patients Enrolled
Martha Morrell, MDPrincipal InvestigatorNeuroPace, Inc.
2 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

RNS System Clinical Trial Eligibility Overview. Trial Name: NCT04839601 — N/A
Partial Seizures Research Study Groups: Evaluation Group (stimulation ON)
Partial Seizures 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this clinical trial?

"This clinical trial necessitates 200 eligible individuals to participate. Westchester Medical Center in Hawthorne, New york and Spectrum Health System in Grand Rapids, Michigan are two registered sites where people can sign-up for the research."

Answered by AI

To which population is admission to this trial restricted?

"This clinical trial seeks 200 individuals, aged 12-17, who suffer from aura and disabling motor simple partial seizures, complex partial seizures, or secondarily generalized seizures. To be eligible for the study, applicants must have no more than two epileptogenic regions; had an average of three or more disruptive episodes in each of the last consecutive 30 day periods; failed treatment with at least two anti-seizure medications; can maintain a diary electronically on their own or with assistance from a responsible individual; able to attend clinic appointments regularly; willing to provide informed consent/assent when required. Further still, those of childbearing potential need to"

Answered by AI

In which medical centers is this research trial taking place?

"At this time, 6 different sites are running the clinical trial in question. These test centres are found in Hawthorne, Grand Rapids and Miami as well other nearby places. To minimize travel requirements if you decide to enroll, it is recommended that you select a site closest to your location of residence."

Answered by AI

Are senior citizens eligible to participate in the clinical trial?

"According to the inclusion criteria, eligible participants of this trial must be aged between 12 and 17. The database displays 123 studies targeting minors while 201 target those aged 65 or above."

Answered by AI

Is there a presently an opportunity to sign up for this experiment?

"As per the information provided on clinicaltrials.gov, this particular trial is still open for recruitment having been first announced on October 27th 2021 with a recent update made on November 11th 2022."

Answered by AI
~93 spots leftby Jul 2026