North American Neuromodulation Society

ION Committees

The following is information about Institute of Neuromodulation (ION) committees.

Lead Interface Committee

The Lead and Device Interface Committee is working to address the issue of standardizing implanted connector designs for neuromodulation devices, as has been done successfully for implanted cardiac pacemakers and defibrillators. Absent compatible connectors, simulator implantation and revision often are constrained, and thus safety, efficacy and cost-effectiveness can be compromised. Connector standards will facilitate independent growth of expertise in the development of leads, implanted generators, power sources and user interfaces.

Following a face-to-face meeting with representatives from industry, regulatory bodies, and standards organizations in DC in 2018, we polled NANS membership and confirmed that there is wide support for standardization.  We are finalizing a manuscript for submission to Neuromodulation and planning a follow-up meeting in DC in 2020.

Clinical group

Richard North, MD (co-chair)
Peter Konrad, MD PhD (co-chair)
Konstantin Slavin, MD
Ashwini Sharan, MD
Parag Patil, MD PhD
Chris Schade, MD PhD

Engineers

Ben Pless
Jack Judy, PhD
Joe Pancrazio, PhD

Clinical Trial Design Standards Committee

The Clinical Trial Committee will uphold the mission of ION by promoting research and innovation to advance the field of Neuromodulation to improve health and quality of life for patients. This committee will stand in the capacity of ensuring quality standards in SCS neuromodulation for research and trial design.  It will ensure proper review of the technology and science to ensure future study designs will be of the highest clinical and cost-benefit merit to advance the field and ensure proper reimbursement by the healthcare system.

Brian Kopell, MD (co-chair)
Steve Falowski, MD 
Lawrence Poree, MD PhD
Nathaniel Katz, PhD
John Markman, MD
Richard North, MD
Rod Taylor, PhD
Sam Eldabe, MB ChB FRCA FFPMRCA
Salim Hayek, MD PhD
Vibhor Krishna, MD SM

The Clinical Trial Committee of IoN has been engaged in producing publications that guide future neuromodulation studies with a first focus on spinal cord stimulation (SCS).  Historically, neuromodulation studies have been hindered by several factors including difficulty of blinding participants, cost, industry sponsorship, lack of appropriate controls… To address these issues, NANS/IoN collaborated with the International Neuromodulation Society (INS) and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to generate two documents. The first manuscript focused on research methodologies for SCS studies, by systematically reviewing published SCS prospective studies.  The second manuscript expanded on research considerations in designing future studies involving spinal cord stimulation.

McNicol E. et al., 2020: Systematic Review of Research Methods and Reporting Quality of Randomized Clinical Trials of Spinal Cord Stimulation for Pain—accepted for publication, Journal of Pain

Katz N. et al., 2020: Research Design Considerations for Randomized Controlled Clinical Trials of Spinal Cord Stimulation for Pain: IMMPACT/ION/Neuromodulation Foundation Recommendations—finalized and ready for submission

Next, the Clinical Committee of IoN will explore design, costs and barriers of prospective studies examining efficacy of neuromodulation approaches compared to other standard therapies.

BASIC SCIENCE IN NEUROMODULATION COMMITTEE

The Basic Science in Neuromodulation Committee will address the tenets of IoN’s vision. Co-chaired by Dr. Lawrence Poree and Dr. Robert Foreman , this committee has been tasked with providing a roadmap to direct basic science research to enhance our understanding of the mechanisms of the action of spinal cord and peripheral nerve stimulation (PNS) for the treatment of pain. The committee will provide a review of what is known and what is not known about the mechanisms of action for SCS and PNS stimulation for pain—and in addition, outline and prioritize scientific questions that will help both industry and governmental funding agencies ultimately improve neuromodulation outcomes for pain management. This committee has been divided into three groups to address their goals; these include the Anatomy/Molecular Group led by Dr. Julie Pilitsis, the Modeling Group led by Dr. Sri Sarma, and the Invitro/Invivo Physiology Group led by Dr. Jeff Ardell and Dr. Lawrence Schramm.

The points below highlight the charge that needs to be addressed by this committee:

  • Identify the problem
  • What makes a discovery meaningful in Neuromodulation?
  • Waveforms?
  • Methods?
  • Applications that define of how the discovery creates Neuromodulation therapy?
  • Define 2-3 fundamental non-clinical procedures with end-points that need to be defined to publish and release discoveries in Neuromodulation
  • Action Items:
  • Meet and develop a roadmap that includes animal anatomical and physiological studies as well as modeling work.
  • Suggest that a primary goal will be to define “pain” by which Neuromodulation devices provide therapy. Examples include using sensors, identifying behavior changes, using genetic testing, etc.

Robert Foreman, PhD (co-chair)
Lawrence Poree, MD PhD (co-chair)
Julie Pilitsis, MD PhD
Yun Guan, MD PhD
Jeff Ardell, PhD
Lawrence Schramm, PhD

Explanted Device Disposition Project

Immediately after the 2020 NANS Annual Meeting, the explanted device disposition project completed a second meeting aimed at developing a consensus statement regarding the disposition of explanted neuromodulation devices. At our first meeting we focused on the ethics and patient rights related to explanted devices. The consensus from our first meeting in December of 2019 was that policies related to explanted devices should prioritize public health first and foremost. Our second meeting focused on and prioritized the disposition of explanted device based on clinical circumstances. Devices explanted for routine expected end of service life would be processed according to the Federal, State, and hospital policies. In many instances these devices are delivered to pathology departments. For devices explanted earlier than expected due to under performance, failure, or patient injury should be processed according to hospital protocol and then transferred to an appropriate agency for in-depth analysis and electronic testing.

Our next meetings will work on further clarification of the types of testing that may be needed and the liability / regulatory consequence of such testing. This committee is dependent on and thankful for the participation of our academic ethicists, patient advocates, industry engineers and legal counsel, as well as our government regulatory consultants. Our goal would be to develop a set of procedures and policies that could be adopted throughout the US by both hospitals and ambulatory surgical centers for the benefit of patients and public health related to explanted neuromodulation devices. 

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