Safety and Effectiveness of Multisite Transcutaneous Spinal Cord Stimulation Combined With Activity-Based Therapy When Delivered in a Community Rehabilitation Setting: A Real-World Pilot Study.

Abstract

Objective: The primary aim of this study was to preliminarily evaluate the safety and efficacy of multisite transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in individuals with chronic spinal cord injury (SCI) when delivered in a community-based neurorehabilitation center.

Materials and methods: Ten participants were enrolled in a nonrandomized pilot trial. Participants completed 120 sessions of tSCS + ABT focused on recovery of upper extremity, trunk, and lower extremity function dependent on their neurologic level of injury. NeuroRecovery Scale (NRS), Berg Balance Scale (BBS), pinch and grasp force, and Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) were obtained at baseline and every 20 sessions. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), quality of life, spasticity, and respiratory measures were assessed at baseline and after 40 and 120 sessions. Nonparametric testing with post hoc correction was used to assess improvements in outcomes.

Results: Median improvements (median [interquartile range]) in NRS-total (Δ1.5 [1.0, 2.0]), NRS-trunk (Δ2.0 [1.2, 3.1]), and BBS scores (Δ2.0 [0, 4.5]) were significant after 120 sessions of tSCS-ABT (all p < 0.013). In the cervical cohort, median improvements in NRS-upper extremity (Δ2.1 [0.6, 2.5]), GRASSP-Sensibility (Δ1.0 [0.0, 1.5]), Prehension ability (Δ2.0 [1.0, 5.5]), and Prehension performance (Δ10.0 [7.5, 13.5]) were significant (all p < 0.05). Post hoc comparisons revealed continued improvements with an increased number of sessions. There were no significant improvements in the ISNCSCI motor and sensory scores as a group; however, three individuals showed improved American Spinal Injury Association Impairment Scale classifications, with four individuals also indicating changes in the neurologic level of injury. No improvements were noted in other exploratory outcomes.

Conclusions: Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating continued improvement. These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI.

Clinical trial registration: The Clinicaltrials.gov registration number for the study is NCT04132596.