RNS® System LTT Study

NCT00572195 | Completed Phase 4 Results DMC

• 2 other identifiers: NP10005P100026
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Epilepsy

Keywords

Epilepsy; Responsive neurostimulation; RNS System; NeuroPace; Brain stimulation; Seizures

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Serious Adverse Events (SAE)

  The number of subjects having an SAE during the RNS® System LTT study.

  2 years post-implant through 9 years post-implant (7 years)

• Percentage Change From Baseline in Seizure Frequency

  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.

  6 months post-implant through 9 years post-implant (8.5 years)

Secondary Outcomes (3)

• Responder Rate

  6 months post-implant through 9 years post-implant (8.5 years)

• QOLIE (Quality of Life in Epilepsy)

  1 year post-implant through 9 years post-implant (8 years)

• Adverse Event Rate

  6 months post-implant through 9 years post-implant (8.5 years)

Study Arms (1)

Evaluation Group (stimulation ON)

EXPERIMENTAL

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

Interventions

RNS® System DEVICE

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. Patients with epilepsy treated with responsive direct-brain stimulation with the RNS System typically receive less than 6 minutes of stimulation a day.

Evaluation Group (stimulation ON)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study
• Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study
• Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study
• Informed consent cannot be obtained from subject or caregiver

Sponsors & Collaborators

• NeuroPace: lead

Study Sites (33)

Mayo Clinic - Arizona

Phoenix, Arizona, 85054, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

University of Florida at Gainesville

Gainesville, Florida, 32610, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Medical College of Georgia / Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Rush University Medical Center / Epilepsy Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Via Christi Comprehensive Epilepsy Center

Wichita, Kansas, 67214, United States

Location

Louisiana State University Epilepsy Center of Excellence

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia University / Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (5)

• 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.

  PMID: 24621228 BACKGROUND

• 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.

  PMID: 21917777 BACKGROUND

• 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.

  PMID: 25616485 RESULT

• Nair DR, Laxer KD, Weber PB, Murro AM, Park YD, Barkley GL, Smith BJ, Gwinn RP, Doherty MJ, Noe KH, Zimmerman RS, Bergey GK, Anderson WS, Heck C, Liu CY, Lee RW, Sadler T, Duckrow RB, Hirsch LJ, Wharen RE Jr, Tatum W, Srinivasan S, McKhann GM, Agostini MA, Alexopoulos AV, Jobst BC, Roberts DW, Salanova V, Witt TC, Cash SS, Cole AJ, Worrell GA, Lundstrom BN, Edwards JC, Halford JJ, Spencer DC, Ernst L, Skidmore CT, Sperling MR, Miller I, Geller EB, Berg MJ, Fessler AJ, Rutecki P, Goldman AM, Mizrahi EM, Gross RE, Shields DC, Schwartz TH, Labar DR, Fountain NB, Elias WJ, Olejniczak PW, Villemarette-Pittman NR, Eisenschenk S, Roper SN, Boggs JG, Courtney TA, Sun FT, Seale CG, Miller KL, Skarpaas TL, Morrell MJ; RNS System LTT Study. Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy. Neurology. 2020 Sep 1;95(9):e1244-e1256. doi: 10.1212/WNL.0000000000010154. Epub 2020 Jul 20.

  PMID: 32690786 DERIVED

• DiLorenzo DJ, Mangubat EZ, Rossi MA, Byrne RW. Chronic unlimited recording electrocorticography-guided resective epilepsy surgery: technology-enabled enhanced fidelity in seizure focus localization with improved surgical efficacy. J Neurosurg. 2014 Jun;120(6):1402-14. doi: 10.3171/2014.1.JNS131592. Epub 2014 Mar 21.

  PMID: 24655096 DERIVED

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Martha Morrell, Chief Medical Officer
• Organization: NeuroPace, Inc.

mmorrell@neuropace.com

650-237-2776

Study Officials

• Martha J Morrell, MD

  NeuroPace, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: April 1, 2006
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 26, 2019
• Results First Posted: June 26, 2019

Record last verified: 2019-05

Locations

US (33)