Feasibility of a Home-based Transcutaneous Spinal Stimulation Program on Autonomic-Cardiovascular Safety After Incomplete Tetraplegia.

OBJECTIVES

We examined the safety and feasibility of delivering a home-based transcutaneous spinal stimulation (TSS) program in persons with incomplete tetraplegia. We also explored the cardiovascular-autonomic safety during the program.

METHODS

Males with chronic incomplete tetraplegia were invited to receive 4 weeks of supervised in-person education and training followed by 16 weeks of home-based training with assistance from a caregiver. Home-based training sessions (3 times weekly) were supervised by secured telehealth video-connect system that included monitoring blood pressure (BP) to ensure cardiovascular safety. Participants were randomized to either a TSS and blood flow restriction enhanced neuromuscular electrical stimulation exercise (BES) program (TSS+BES) or a sham TSS+BES group. Measurements were conducted at baseline 1 (BL1), BL2, post intervention (PI), and follow-up (Fw) including 60-degree head tilt with monitoring of blood pressure (BP) and pulmonary function tests.

RESULTS

Six participants completed the entire feasibility trial and were randomized into TSS+BES (n = 4) or sham TSS+BES (n = 2). Adherence rates were 80% ± 15% and 95% ± 7% for the TSS+BES and sham TSS+BES groups, respectively. Ten qualified participants were unable to enroll because of failure to identify a dedicated caregiver. No adverse events were reported during the trial. Home-based autonomic-cardiovascular safety of TSS+BES was ensured via reporting systolic BP during the entire session and absence of episodes of autonomic dysreflexia or orthostatic hypotension during the trial.

CONCLUSION

Home-based TSS is a feasible rehabilitation approach after incomplete tetraplegia. The feasibility trial provided evidence for the cardiovascular safety of TSS, with no participants developing autonomic adverse events over the 20-week education and training intervention period. Future clinical trials may deliver home-based TSS with caregiver assistance and telehealth supervision to increase access to neuromodulation treatment that may enhance autonomic nervous system and hemodynamic stability in persons with SCI.