A word cloud featuring terms like Clinical Trial, Phase, Safety, Brain, Efficacy, Stimulation, Spinal Cord, Nerve, and Devices in blue and yellow text.

Clinical Trial Design Standards

The Clinical Trial Design Standards Committee will provide expertise for ensuring high standards in neuromodulation 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.

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

The Clinical Trial Committee of IoN has been engaged in producing publications that guide future neuromodulation studies, focusing first 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 has collaborated with the International Neuromodulation Society (INS) and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), and several publications have resulted. The first three systematically reviewed and analyzed published SCS prospective studies, their reporting quality, and the use of sham and placebo controls. The fourth and most recent manuscript expanded on research considerations in designing future SCS studies and set forth detailed recommendations. 

​Upcoming Events​

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.