RNS® System Epilepsy PAS

Epilepsy Clinical Trial

Official title:

RNS® System Post-Approval Study in Epilepsy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02403843
• Other study ID #: NP10012
• Secondary ID: PMA100026
• Status: Active, not recruiting
• Start date: April 2015
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: NeuroPace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified CECs by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.

Description:

NeuroPace, Inc. is sponsoring a post-approval study (PAS) of the RNS System device. The RNS System is the first FDA-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures.

The RNS System Epilepsy PAS is a 5 year, non-randomized, open-label, multi-center prospective observational study. Data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study.

The study is designed to assess the long-term safety and effectiveness of the RNS System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures).

Data from the RNS System Epilepsy PAS will be used to calculate long-term SAE rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 375
• Est. completion date: January 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

A clinical decision to treat the patient with the RNS System in accordance with its approved indication for use has been made prior to enrollment in the study. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).

This post-approval study also has the following additional study related inclusion criteria:

• Subject or legal guardian is able to provide appropriate consent to participate

• Subject is able to maintain a seizure diary alone or with the assistance of a competent individual

• Subject is able to attend clinic appointments in accordance with the study schedule

Exclusion Criteria:

Per clinician assessment, treatment with the RNS System is contraindicated based on current RNS System labeling. For approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com).

This post-approval study has the following additional study related exclusion criteria:

• Subject is participating in a therapeutic investigational drug or device study

• Subject was treated with a VNS within the last three months (90 days)

• Subject is pregnant

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• RNS System
The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Austin Epilepsy Care Center	Austin	Texas
United States	Seton Family of Hospital	Austin	Texas
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Pennsylvania State University / Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Dartmouth-Hitchcock Medical Cente	Lebanon	New Hampshire
United States	University of Kentucky	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	NYU Langone Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Intermountain Healthcare Research	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	Swedish Health Services	Seattle	Washington
United States	University of Washington Harborview Medical Center	Seattle	Washington
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NeuroPace

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bergey GK, Morrell MJ, Mizrahi EM, Goldman A, King-Stephens D, Nair D, Srinivasan S, Jobst B, Gross RE, Shields DC, Barkley G, Salanova V, Olejniczak P, Cole A, Cash SS, Noe K, Wharen R, Worrell G, Murro AM, Edwards J, Duchowny M, Spencer D, Smith M, Geller E, Gwinn R, Skidmore C, Eisenschenk S, Berg M, Heck C, Van Ness P, Fountain N, Rutecki P, Massey A, O'Donovan C, Labar D, Duckrow RB, Hirsch LJ, Courtney T, Sun FT, Seale CG. Long-term treatment with responsive brain stimulation in adults with refractory partial seizures. Neurology. 2015 Feb 24;84(8):810-7. doi: 10.1212/WNL.0000000000001280. Epub 2015 Jan 23. — View Citation

Heck CN, King-Stephens D, Massey AD, Nair DR, Jobst BC, Barkley GL, Salanova V, Cole AJ, Smith MC, Gwinn RP, Skidmore C, Van Ness PC, Bergey GK, Park YD, Miller I, Geller E, Rutecki PA, Zimmerman R, Spencer DC, Goldman A, Edwards JC, Leiphart JW, Wharen RE, Fessler J, Fountain NB, Worrell GA, Gross RE, Eisenschenk S, Duckrow RB, Hirsch LJ, Bazil C, O'Donovan CA, Sun FT, Courtney TA, Seale CG, Morrell MJ. Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Epilepsia. 2014 Mar;55(3):432-41. doi: 10.1111/epi.12534. Epub 2014 Feb 22. — View Citation

Morrell MJ; RNS System in Epilepsy Study Group. Responsive cortical stimulation for the treatment of medically intractable partial epilepsy. Neurology. 2011 Sep 27;77(13):1295-304. doi: 10.1212/WNL.0b013e3182302056. Epub 2011 Sep 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurostimulator battery longevity	Characterize the clinically observed battery longevity over time and in relation to therapy load in patients treated with the RNS System.
Primary	SAE rate	Calculate annual SAE rates over time in the entire subject population as well as within subpopulations.	Implant through 5 years post-implant
Primary	Neurosurgeon experience	Demonstrate there is no difference in safety in 6-week perioperative period based on the experience of NeuroPace qualified and trained implanting physicians.	Implant through 41 days post-implant
Primary	Physician experience	Demonstrate there is no difference in safety 1 year post-implant based on experience of NeuroPace qualified and trained treating physicians and Comprehensive Epilepsy Centers.	Implant through 1 year post-implant
Primary	Product use - surgical procedures	Present the incidence and number of AEs related to surgical procedures associated with implant, explant, reimplantation, and revision of the neurostimulator and lead(s).
Primary	Autopsy	Present data from autopsies obtained from any patient implanted with neurostimulator/leads.
Primary	Median percentage reduction in disabling seizure	Demonstrate that the median percentage reduction in disabling seizures over time in the entire subject population is comparable to the median percentage reduction in disabling seizures over time in the LTT study. Characterize the median percentage reduction in disabling seizures over time within subpopulations.	Pre-implant (retrospective data) compared to 30 to 36 months post-implant
Primary	Neurostimulator programming	Demonstrate that stimulation programming classes have similar effects on the overall seizure frequency.	Through 5 years post-implant
Secondary	Seizure worsening	Demonstrate that there is not a worsening in disabling seizures over time in the entire subject population. Assess the sustained effect on disabling seizure frequency over time within subpopulations.	6 months post-implant through 36 months post-implant
Secondary	Neurostimulator programming	Characterize the effects of stimulation programming classes on the overall 5-year rate of SAEs and device-related non-serious AEs.	Implant through 5 years post-implant