INSTITUTE OF

NEUROMODULATION (ION)

Promote research and innovation to advance neuromodulation

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. 
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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. Journal of Pain: 2020 Jun 20:S1526-5900(20)30040-7. doi: 10.1016/j.jpain.2020.05.001.

Katz N. et al., 2021: Research Design Considerations for Randomized Controlled Trials of Spinal Cord Stimulation for Pain: IMMPACT/ION/INS Recommendations. Pain: January 18, 2021,  doi: 10.1097/j.pain.0000000000002204 

Duarte RV et al, 2022: Reporting Guidelines for Clinical Trial Protocols and Reports of Implantable Neurostimulation Devices: Protocol for the SPIRIT-iNeurostim and CONSORT-iNeurostim Extensions, Neuromodulation 25:1045-1049. ​

​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.

ION PROJECTS OVERVIEW