Cervical spinal cord injury (SCI) leads to upper extremity impairment which can significantly impact the quality of life (QoL) of patients.¹ ARC^EX Therapy, an external device that delivers targeted transcutaneous spinal cord stimulation, has been developed to facilitate functional recovery in SCI patients.¹ At the AAN 2024 Annual Meeting, Dr. Candace Tefertiller from Craig Hospital, Denver, the United States (US), presented results from the Up-LIFT Pivotal and LIFT Home trials which were conducted to assess the safety and effectiveness of ARC^EX Therapy delivered during functional task practice (FTP) in improving upper extremity strength and function among participants with chronic cervical SCI in the in-clinic and at home.¹

In the Up-LIFT trial, 65 individuals aged 22-75 years with chronic, incomplete cervical SCI (C2-C8 inclusive, American Spinal Injury Association Impairment Scale [AIS] grade B, C or D) were enrolled across 14 sites in the US, Canada, United Kingdom and the European Union.¹ All individuals first underwent a 2-month, intensive, standardized, in-clinic rehabilitation program (FTP-only phase), followed by ARC^EX Therapy with rehabilitation (FTP + ARC^EX Therapy phase) for an additional 2 months.¹ Sensorimotor assessment scores and patient-reported outcomes were recorded at baseline and following each month.¹

The primary safety endpoint was the incidence of device-related serious adverse events, while the primary effectiveness endpoint assessed if participants achieved clinically meaningful improvements (≥1 strength and ≥1 function metric) during the FTP + ARC^EX Therapy phase.¹ Responder criteria were defined as: ≥2-point improvement in International Standards for Neurological Classification of Spinal Cord Injury-upper extremity motor score (ISNCSCI-UEMS), ≥2.4N for pinch force, ≥6N grasp force, or ≥ 4 points in the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP) strength.¹

Secondary analyses compared responder rates and improvements in sensorimotor and QoL outcomes between FTP + ARC^EX Therapy and FTP alone.¹ These included significantly higher responder rates (83% vs 63%, p=0.012) and greater gains in measures like pinch force, GRASSP, ISNCSCI-UEMS and ISNCSCI-Total Sensory Score, and the European 5-Dimension 5-Level Quality of Life Questionnaire (EQ-5D-5L) QoL after the combined therapy.¹

No device-related serious adverse events were reported and 72% of participants (n=60) met the responder criteria during the FTP + ARC^EX Therapy phase, with significant improvements across all strength and function metrics except pinch force.¹ Secondary analyses found significantly higher responder rates after FTP + ARC^EX Therapy compared to after FTP alone (83% vs. 63%; p=0.012), as well as greater improvements in sensorimotor outcomes such as pinch force (7.3 vs. 2.6; p=0.002), GRASSP Prehension Performance (2.9 vs. 1.3; p<0.001), GRASSP Strength (6.4 vs. 3.6; p<0.001), ISNCSCI-UEMS (2.3 vs. 0.2; p<0.001), ISNCSI-Total Sensory Score (7.8 vs. -1.8; p<0.001) and QoL (EQ-5D-5L: 6.5 vs. 4.8; p=0.028).¹ Responder rates also varied by AIS subgroup (AIS B: 44%, AIS C: 89%, AIS D: 61%).¹

In the LIFT Home trial, 17 individuals who had completed the Up-LIFT trial within 12 months received an additional 1 month of FTP + ARC^EX Therapy at home with caregiver aid.¹ The trial aimed to establish the safety and feasibility of home-based ARC^EX Therapy.¹ Similar to the UP-LIFT trial, there were no device-related serious adverse events reported during at-home therapy.¹ Feasibility was assessed by comparing at-home to in-clinic treatment adherence, which was high – participants completed equivalent numbers of sessions per month (12.3 at home vs. 13.0 in clinic; p=0.168).¹

Effectiveness after 1 month of at-home therapy was also evaluated. CUE-T scores (mean change=2.2; p=0.025) and pinch forces (mean change=6.9N; p=0.02) significantly improved, while other in-clinic gains were maintained or further extended.¹ Patient-reported outcomes also showed benefits, including reduced pain (International Spinal Cord Injury Pain Data Set [ISCIPDS] score mean change=-0.6; p=0.019), improved psychological health (World Health Organization Quality of Life Brief Version [WHOQoL-BREF] mean change: 3.4; p=0.025), and better self-care (Spinal Cord Independent Measure [SCIM III] mean change=0.2; p=0.042).¹ These results supported the safety and feasibility of delivering ARC^EX Therapy in the home setting.¹

In summary, the results of these trials show that when delivered during FTP either in-clinic or at-home, ARC^EX Therapy is a safe and effective treatment to improve upper extremity strength and function in patients with chronic, cervical SCI.¹ Sensorimotor improvements also translated to improvements in self-reported measures of QoL in both trials.¹ Moreover, therapy dosages achieved at home were equivalent to those completed in-clinic, highlighting the system usability, treatment adherence and logistical advantages of at-home access to therapy.¹