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

  Show 33 Study Locations
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 September 22, 2014