RNS® System Epilepsy Post-Approval Study

Active, not recruitingOBSERVATIONAL
Enrollment

375

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

December 31, 2023

Study Completion Date

January 31, 2026

Conditions
Epilepsy
Interventions
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.

Trial Locations (35)

10016

NYU Langone Medical Center, New York

17033

Pennsylvania State University / Milton S. Hershey Medical Center, Hershey

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

27514

University of North Carolina at Chapel Hill, Chapel Hill

30322

Emory University, Atlanta

35294

University of Alabama, Birmingham, Birmingham

37232

Vanderbilt University, Nashville

38105

Le Bonheur Children's Hospital, Memphis

40241

Norton Neuroscience Institute, Louisville

40506

University of Kentucky, Lexington

44193

The Cleveland Clinic Foundation, Cleveland

46202

Indiana University, Indianapolis

49503

Spectrum Health, Grand Rapids

53705

University of Wisconsin-Madison, Madison

60612

Rush University Medical Center, Chicago

68198

University of Nebraska Medical Center, Omaha

78701

Seton Family of Hospital, Austin

78758

Austin Epilepsy Care Center, Austin

80045

University of Colorado Denver, Aurora

84157

Intermountain Healthcare Research, Salt Lake City

90032

University of Southern California, Los Angeles

90095

University of California, Los Angeles, Los Angeles

92868

University of California, Irvine, Irvine

94143

University of California, San Francisco, San Francisco

94304

Stanford University, Palo Alto

98104

University of Washington Harborview Medical Center, Seattle

98122

Swedish Health Services, Seattle

06520

Yale University, New Haven

Unknown

University of South Florida, Tampa

The University of Texas Health Science Center at Houston, Houston

02114

Massachusetts General Hospital, Boston

03756

Dartmouth-Hitchcock Medical Cente, Lebanon

75390-9036

University of Texas Southwestern Medical Center, Dallas

84132-5901

University of Utah, Salt Lake City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NeuroPace

INDUSTRY