Neuromodulation therapies are being developed and deployed at a fast pace. Research of high quality is required to establish a scientific basis to guide clinical practice and to ensure delivery of efficacious and safe neuromodulation therapies to patients and support from governments, funders, and regulatory agencies. The traditional RCT design has undergone several innovative modifications. The use of large databases that include patient-reported and relevant outcomes has opened the possibility of answering research questions in neuromodulation with confidence. This session will focus on innovations in RCT design, ways to involve funders and regulators in the research process, and explore processes for developing robust systems to sustain ongoing research in neuromodulation.
Upon completion of this educational activity, participants should be able to:
- Identify the limitations of the traditional RCT design and recent innovations in trial designs for neuromodulation.
- Describe challenges and propose avenues to getting support from funders and approvers of neuromodulation therapies.
- Examine how big data can provide critical information about the efficacy and safety of neuromodulation therapies.
- Discuss research methodologies for ascertaining the use of neuromodulation therapies off-label for new and/or orphan indications.
Anuj Bhatia, MD
2020 IMMPACT/ION/INS Recommendations for Randomized Controlled Trials of Spinal Cord Stimulation for Pain
Nathaniel P. Katz, MD MS
Generating and Using Big Data to Conduct, Augment and Extend Existing Research Designs
Anuj Bhatia, MD
Developing National and International Registries for Neuromodulation
Joohi Jimenez-Shahed, MD
Faculty and Presentations subject to change.