Study design considerations in clinical trials testing transcutaneous stimulation for spinal cord injury

Authors: Guest, J. and Moritz, C. 

Publication: Spinal Cord

Date: March, 2026

Abstract: The unique challenges of tSCS clinical trials necessitate innovative methodological approaches beyond traditional placebo-controlled designs. Sequential self-controlled designs, biomarker-guided studies, and adaptive trial methodologies offer scientifically sound alternatives that respect participant welfare while generating robust evidence. Future research should pursue dual paths: developing improved sham paradigms while advancing alternative trial methodologies suitable for neuromodulation-enhanced rehabilitation interventions.

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