Trial record 1 of 1 for:    RNS LTT
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RNS® System Long-term Treatment (LTT) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
NeuroPace
ClinicalTrials.gov Identifier:
NCT00572195
First received: December 10, 2007
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy 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 that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.


Condition Intervention Phase
Epilepsy
Device: RNS® System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RNS® System Long-term Treatment Clinical Investigation

Resource links provided by NLM:


Further study details as provided by NeuroPace:

Primary Outcome Measures:
  • Long-term SAE rate [ Time Frame: 2 years post-implant through 9 years post-implant (7 years) ] [ Designated as safety issue: Yes ]
    The proportion of subjects having a serious adverse event (SAE) during the RNS® System LTT study.

  • Change in seizure frequency over the long-term [ Time Frame: 6 months post-implant through 9 years post-implant (8.5 years) ] [ Designated as safety issue: No ]
    The average percentage change in the mean frequency of total disabling seizures relative to pre-implant baseline. The percent change will be calculated for each subject over 6-month intervals beginning 6 months after RNS® System implant and continuing through completion of the RNS® System LTT study.


Enrollment: 230
Study Start Date: April 2006
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Evaluation Group (stimulation ON)
Group of subjects that have an RNS® System implanted, completed the RNS® System Pivotal or Feasibility study, and elected to continue to receive RNS® System responsive stimulation for the long term.
Device: RNS® System
The previously implanted RNS® System is programmed to provide responsive stimulation. Upon detecting electrographic patterns, previously identified by the neurologist or neurosurgeon as abnormal, 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.

Detailed Description:

NeuroPace, Inc. is sponsoring an investigational device study of the RNS® System, the first closed loop responsive brain stimulator designed to treat refractory epilepsy. The RNS® System LTT study is an open-label multi-center prospective 7-year clinical investigation which follows completion of the RNS® System Pivotal or Feasibility study. Data regarding safety and efficacy are collected at 6-month intervals, and data regarding quality of life are collected at yearly intervals.

The study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of medically uncontrolled and disabling partial onset seizures that start from one or two areas of the brain.

The RNS® System LTT study will provide additional data on the safety and efficacy of the RNS® System for 7 years following a subject's completion of the RNS® System Feasibility or Pivotal studies. Data from the RNS® System LTT study will be combined with data collected during the RNS® System Feasibility and Pivotal studies, resulting in 9 total years of post-implant follow-up data. These data will be used to calculate long-term SAE rate, percent change in seizure frequency (from pre-implant baseline), as well as the frequency of sudden unexplained death in epilepsy (SUDEP).

The RNS® Neurostimulator (a pacemaker-like device) and NeuroPace® Leads (tiny wires with electrodes) are implanted in the head. The Neurostimulator is a battery powered, microprocessor controlled device that detects and stores records of electrographic patterns (such as epileptiform, or seizure-like, activity) from the Leads within the brain. When the device detects an electrographic pattern, it responds by sending electrical stimulation through the Leads to a small part of the patient's brain to interrupt the electrographic pattern. This type of treatment is called responsive stimulation, but it is not yet known if it will work for the treatment of epilepsy. Direct brain stimulation therapy has already received approval in the United States, Europe, Canada, and Australia for the treatment of Essential Tremor and Parkinson's disease. Direct brain stimulation is not approved for the treatment of epilepsy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has completed either the RNS® System Pivotal or Feasibility study
  2. Subject has an implanted RNS® System
  3. Subject has elected to continue to receive responsive neurostimulation therapy after completion of the RNS® System Pivotal or Feasibility study
  4. Subject is able to attend scheduled appointments for the RNS® System LTT study

Exclusion Criteria:

  1. Subject has active psychiatric or medical illness that makes it inadvisable for the subject to continue to receive responsive neurostimulation therapy with the RNS® System
  2. Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study
  3. Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study
  4. Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study
  5. Informed consent cannot be obtained from subject or caregiver
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572195

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85054
United States, California
University of Southern California
Los Angeles, California, United States, 90033
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
University of Florida at Gainesville
Gainesville, Florida, United States, 32610
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Medical College of Georgia / Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Rush University Medical Center / Epilepsy Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
Via Christi Comprehensive Epilepsy Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Louisiana State University Epilepsy Center of Excellence
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Columbia University / Columbia Presbyterian Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
NeuroPace
  More Information

No publications provided by NeuroPace

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NeuroPace
ClinicalTrials.gov Identifier: NCT00572195     History of Changes
Other Study ID Numbers: NP10005
Study First Received: December 10, 2007
Last Updated: June 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NeuroPace:
Epilepsy
Responsive neurostimulation
RNS System
NeuroPace
Brain stimulation
Seizures

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 23, 2014