Home-Based Noninvasive Spinal Cord Stimulation Safely Enhances Hand and Arm Function in People With Spinal Cord Injury.

BACKGROUND AND

OBJECTIVES

The Up-LIFT Trial demonstrated that in-clinic rehabilitation augmented by noninvasive spinal cord stimulation (ARCEX Therapy) safely and effectively improved upper extremity strength and function in people with chronic incomplete cervical spinal cord injury (SCI). As a follow-up study, LIFT Home, a single-arm interventional trial, investigated the safety, usability, and benefits of ARCEX Therapy during home use.

METHODS

Seventeen participants from the Up-LIFT Trial continued with ARCEX Therapy at home for 1 month. Primary endpoints evaluated the safety and feasibility of at-home ARCEX Therapy. Secondary efficacy outcomes included the Capabilities of Upper Extremity Test (CUE-T); the Graded Redefined Assessment of Strength, Sensation, and Performance; pinch and grasp forces; and global impression of change scores. Additional post hoc analysis examined the effect of different periods of time without treatment, and the potential of home-based therapy to maintain or extend improvements achieved in-clinic. Finally, quality of life and independence were assessed through participant-reported surveys.

RESULTS

There were no serious adverse events related to the device or major usability issues that interfered with home-based treatment. Compliance with the prescribed therapy was high and mirrored in-clinic therapy dosages, with participants completing 12.3 ± 2.9 sessions each lasting 59 ± 10 minutes on average. Average CUE-T scores and pinch forces significantly improved (Δ2.2 ± 4.1, p = 0.025 and Δ6.9 N ± 15.5, p = 0.020, respectively), as did pain interference with day-to-day activities (International SCI Pain Data Set subscore Δ-0.6 ± 1.2, p = 0.019), psychological health (World Health Organization Quality of Life-BREF subscore Δ3.4 ± 5.8, p = 0.025), and self-care ability (Spinal Cord Independence Measure III subscore Δ0.2 ± 0.4, p = 0.042). Improvements were most apparent in individuals who responded to prior in-clinic ARC EX Therapy. Notably, post hoc analysis revealed that functional decline following periods of inactivity can be reversed, and in-clinic progress can be further enhanced with at-home ARCEX Therapy.

DISCUSSION: This study suggests ARCEX Therapy can be safely used at home to continue to improve strength and function. It is important that at-home therapy may be essential to maintain intervention-related in-clinic gains.

TRIAL REGISTRATION INFORMATION: The LIFT Home Trial was registered on clinicaltrials.gov (NCT05284201, clinicaltrials.gov/study/NCT05284201) on September 03, 2022. The first participant was enrolled on March 03, 2022.