Abstract
BACKGROUND: Emerging neuromodulation approaches, including epidural electrical stimulation (EES), offer hope for restoration of function following chronic spinal cord injury (SCI). However, integrating neuromodulation therapies into clinical procedures is challenging due to the unique needs of the SCI population. OBJECTIVES: The purpose of this study was to understand the experiences of participants during a first-in-human trial of perilesional EES aimed at restoring sensorimotor function. METHODS: We report participants' experiences by describing their clinical care, experiences during experimental neuromodulation sessions, and perspectives on the utility of a perilesional EES system. Three participants with chronic thoracic SCI participated in semistructured interviews after completing a 14-day inpatient experimental protocol, which included stimulation mapping, lower extremity motor control experiments, and treadmill stepping. Interview data were analyzed using an applied thematic analysis approach. Nine key themes addressed 4 major topic areas: clinical experiences, experiences during laboratory experiments, experiences as a research participant, and perceived value of perilesional EES. RESULTS: All participants noted the potential for EES to enhance functional recovery, though their postoperative experiences related to clinical care, postoperative pain, and disruptions to routine care differed. Insights gained from qualitative analyses highlighted challenges and opportunities for improving postsurgical care and refining application of EES technology. Further, these results inform recommendations for neuromodulation trials in the SCI community to help mitigate postoperative complications and improve study participant experiences. CONCLUSION: Key recommendations include being proactive regarding potential postsurgical complications, educating clinical staff regarding common SCI comorbidities, and customizing experimental protocols to align with the priorities and clinical needs of each participant.