RNS® System Feasibility Study

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

May 31, 2006

Study Completion Date

December 31, 2007

Conditions
Epilepsy
Interventions
PROCEDURE

RNS® System implantation

Using standard neurosurgical techniques the surgical team implants the RNS® System, which includes the RNS® Neurostimulator and intracranial NeuroPace® Leads. Up to 4 Leads (Cortical Strips and/or Depth Leads) are placed in or near the epileptogenic focus/foci. The Neurostimulator is placed in the skull and connected to up to 2 Leads. At first the Neurostimulator is programmed to record brain activity (electrographic patterns). The neurologist or neurosurgeon reviews the recorded electrographic patterns and identifies abnormal (epileptiform, or seizure-like) activity. The Neurostimulator is then programmed to detect the abnormal activity.

DEVICE

RNS® System responsive stimulation

The RNS® System is programmed to provide responsive stimulation (stimulation is ON or enabled). Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal (epileptiform, or seizure-like) activity, the Neurostimulator provides brief pulses of electrical stimulation through the Leads to interrupt those patterns. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.

Trial Locations (12)

10021

Weill Medical College of Cornell University, New York

10032

Columbia University / Columbia Presbyterian Medical Center, New York

21287

Johns Hopkins University School of Medicine, Baltimore

30912

Medical College of Georgia, Augusta

32224

Mayo Clinic Jacksonville, Jacksonville

48202

Henry Ford Hospital, Detroit

55905

Mayo Clinic Rochester, Rochester

60612

Rush University Medical Center / Epilepsy Center, Chicago

70112

Louisiana State University Epilepsy Center of Excellence, New Orleans

85054

Mayo Clinic Scottsdale, Phoenix

98122

Swedish Medical Center, Seattle

06520

Yale University School of Medicine, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NeuroPace

INDUSTRY