RNS System RESPONSE Study

NCT04839601 | Terminated DMC FDA Device

• 1 other identifier: NP10014
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.

Conditions

Epilepsy; Partial Seizure; Neurostimulator; Complications; Drug Resistant Epilepsy; Focal Epilepsy

Keywords

Adolescent; Medically refractory; Responsive neurostimulation; Focal onset seizures; RNS System

Outcome Measures

Primary Outcomes (2)

• Short-term chronic serious adverse device effect (SADE) rate

  The primary safety endpoint is the percent of subjects with serious device-related adverse events at 84 days (12 weeks) post-implant.

  84-days post-implant

• Responder rate at 12 months post implant

  12 months post-implant

  The primary effectiveness endpoint is the percent of subjects with a ≥ 50% reduction in seizures at 12 months post-implant compared to the pre-implant baseline.

Other Outcomes (6)

• Device-related Serious Adverse Event (SADE) event rate

  Implant through 2 years post-implant

• Event rate of Serious Adverse Events (SAEs) of particular relevance

  Implant through 2 years post-implant

• Affective status as measured by the Beck Depression Inventory

  Implant through 2 years post-implant

Study Arms (1)

Evaluation Group (stimulation ON)

EXPERIMENTAL

Group of participants that have an RNS System implanted and are being treated with responsive stimulation.

Device: RNS System

Interventions

RNS System DEVICE

The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.

Evaluation Group (stimulation ON)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or parent/caregiver.
• Subject had an average of three or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures over the two most recent consecutive 30-day periods, with no 30-day period with less than two seizures per subject and/or parent/caregiver report.
• Subject failed treatment with a minimum of two anti-seizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
• Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions.
• Subject is male or a female of childbearing potential using a reliable method of contraception (hormonal, barrier method, surgical or abstention).
• 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.
• Subject is able to maintain an electronic diary alone or with the assistance of a competent individual.
• Subject is able to attend clinic appointments in accordance with the study schedule.
• Subject and/or parent/guardian must be willing and able to provide informed consent and assent when appropriate.
• Subject is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
• In the investigator's opinion, subject is able to tolerate a neurosurgical procedure.

You may not qualify if:

• Subject has been diagnosed with primarily generalized seizures.
• Subject requires procedures that are contraindicated based on current RNS System labeling.
• In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
• Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded.
• Subject is pregnant.
• Subject is participating in a therapeutic investigational drug or other device study.
• Subject is implanted with an electronic medical device that delivers electrical energy to the brain.
• Subject has been diagnosed with psychogenic or non-epileptic seizures.
• Subject has experienced unprovoked status epilepticus in the preceding year.
• Subject is taking chronic anticoagulants.
• Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).

Sponsors & Collaborators

• NeuroPace: lead

Study Sites (2)

Spectrum Health System

Grand Rapids, Michigan, 49503, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

Related Publications (1)

• Nair DR, Laxer KD, Weber PB, Murro AM, Park YD, Barkley GL, Smith BJ, Gwinn RP, Doherty MJ, Noe KH, Zimmerman RS, Bergey GK, Anderson WS, Heck C, Liu CY, Lee RW, Sadler T, Duckrow RB, Hirsch LJ, Wharen RE Jr, Tatum W, Srinivasan S, McKhann GM, Agostini MA, Alexopoulos AV, Jobst BC, Roberts DW, Salanova V, Witt TC, Cash SS, Cole AJ, Worrell GA, Lundstrom BN, Edwards JC, Halford JJ, Spencer DC, Ernst L, Skidmore CT, Sperling MR, Miller I, Geller EB, Berg MJ, Fessler AJ, Rutecki P, Goldman AM, Mizrahi EM, Gross RE, Shields DC, Schwartz TH, Labar DR, Fountain NB, Elias WJ, Olejniczak PW, Villemarette-Pittman NR, Eisenschenk S, Roper SN, Boggs JG, Courtney TA, Sun FT, Seale CG, Miller KL, Skarpaas TL, Morrell MJ; RNS System LTT Study. Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy. Neurology. 2020 Sep 1;95(9):e1244-e1256. doi: 10.1212/WNL.0000000000010154. Epub 2020 Jul 20.

  PMID: 32690786 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy; Epilepsies, Partial

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha Morrell, MD

  NeuroPace, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: October 27, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)