Neuromodulation Unmasked: Navigating the Intersection of Quality, Bias, Ethics, and Fragility in the Current Literature

This session will embark on a comprehensive exploration of critical dimensions in neuromodulation research. The session will take a deep dive into the methodological rigors of various study designs in the neuromodulation literature including RCTs, systematic reviews and meta-analyses, scoping reviews, as well as guidelines. We will specifically evaluate the quality of these study designs and how they measure up to standardized and validated reporting tools including PRISMA-ScR, AGREE, and RIGHT checklists. In relation to this, we will also assess compliance with reporting multidimensional outcomes in clinical trials, concordant with the IMMPACT guidelines. In addition, attendees will gain valuable insights into the intricacies of funding structures and conflicts of interest within randomized controlled trials and guidelines in neuromodulation. Due to the limitations in study design including lack of placebo-controlled trials, presence of industry bias, and other weaknesses, this panel will also unravel the complexities surrounding the design of an ideal, non-biased placebo-controlled randomized trial, addressing ethical considerations, feasibility challenges, funding dynamics, and the overarching impact on advancing neuromodulation research. Finally, we will explore the 'fragility' of data and the clinical significance derived from neuromodulation trials, offering a nuanced perspective on the robustness of evidence in this dynamic field. All talks within this plenary session have been inspired by current work, both current featured publications and upcoming research that is being submitted for publication. It is our hope that by outlining issues with the current landscape of neuromodulation in related to quality, bias, ethics, and fragility, we will motivate future higher-quality work that will have greater impact in advancing the field.