Clinical Trial Design Standards

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)
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

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.

Duarte, R.V. et al., 2020: Randomized Placebo‐/Sham‐Controlled Trials of Spinal Cord Stimulation: A Systematic Review and Methodological Appraisal. Neuromodulation. doi:10.1111/ner.13018

Duarte, R.V. et al., 2020: Systematic Review and Meta-Analysis of Placebo/Sham Controlled Randomised Trials of Spinal Cord Stimulation for Neuropathic Pain. Pain 161:24-30

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; in press May 2020

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

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.