Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.

Abstract

Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices. From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed. Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of the studies.