Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy) Is Safe and Effective at Improving Upper Extremity Function Following Spinal Cord Injury
Candace Tefertiller1, Randy Trumbower2, Leslie Morse3, Ilse van Nes4, Sukhvinder Kalsi-Ryan5, Mariel Purcell6, Thomas Janssen7, Andrei Krassioukov8, Kristin Zhao9, James Guest10, Ralph Marino11, Lynda Murray12, Jill Wecht13, Markus Rieger14, Jared Pradarelli14, Jenny Suggitt14, Amanda Turner14, Kristen Gelenitis14, Jessica D'Amico15, Chet Moritz16, Edelle Field-Fote17
1Department of Physical Therapy, Craig Hospital, 2Spaulding Rehabilitation Hospital; Department of Physical Medicine and Rehabilitation, Harvard Medical School, 3Department of Rehabilitation Medicine, University of Minnesota School of Medicine, 4Sint Maartenskliniek, afd. Revalidatiegeneeskunde, 5KITE Research Institute | Toronto Rehab, University Health Network, 6Scottish Centre for Innovation in Spinal Cord Injury, Queen Elizabeth National Spinal Injuries Unit, Queen Elizabeth University Hospital, 7Amsterdam Rehabilitation Research Center | Reade; Department of Behavioral and Movement Sciences, Vrije Universiteit Amsterdam, 8ICORD and Division of Physical Medicine and Rehabilitation, University of British Columbia, 9Rehabilitation Medicine Research Center, Department of Physical Medicine and Rehabilitation, Mayo Clinic, 10The Miami Project to Cure Paralysis; Neurological Surgery, Miller School of Medicine, University of Miami, 11Thomas Jefferson University Hospital, 12James J Peters VA Medical Center; Departments of Rehabilitation and Human Performance, and Medicine, 13James J Peters VA Medical Center, Department of Research & Development; Departments of Rehabilitation and Human Performance, and Medicine, Icahn School of Medicine Mount Sinai, 14ONWARD Medical, 15ONWARD Medical; Glenrose Rehabilitation Hospital, Department of Medicine, University of Alberta, 16Departments of Rehabilitation Medicine, Electrical & Computer Engineering, Physiology & Biophysics, and Center for Neurotechnology, University of Washington, 17Shepherd Center, Crawford Research Institute; Department of Rehabilitation Medicine, Emory University School of Medicine
Objective:
To determine the safety and effectiveness of ARCEX Therapy delivered in the clinic and home setting.
Background:
Cervical SCI leads to upper extremity (UE) impairment significantly altering quality of life. ARCEX Therapy, which combines transcutaneous spinal cord stimulation with functional task practice (FTP), may facilitate functional recovery in this population.
Design/Methods:
Sixty-five participants enrolled in a prospective, single-arm, multicenter trial (Up-LIFT, NCT04697472) that included a run-in period of two months of UE FTP, followed by an equivalent period of ARCEX Therapy, with stimulation delivered over the cervical spinal cord. Within 12 months of completion of in-clinic ARCEX Therapy, seventeen individuals subsequently enrolled in one month of therapy delivered in the home setting with the aid of a caregiver (LIFT Home, NCT05284201). The primary safety endpoint for both trials reported device-related serious adverse events (SAEs). Effectiveness was evaluated utilizing a composite responder score to assess whether the majority of participants achieved clinically significant improvements in at least one strength (ISNCSCI-UEMS, GRASSP Strength, pinch and grasp force) and at least one function metric (CUE-T and GRASSP Prehension) during the ARCEX Therapy phase of the Up-LIFT Trial. Similar effectiveness outcomes were obtained during the LIFT Home Trial (excluding UEMS).
Results:
No SAEs related to ARCEX Therapy were reported in any of the individuals who participated in clinic or home-based therapy. Of sixty participants who completed the in-clinic ARCEX Therapy phase, 72% met the predefined primary effectiveness endpoint. CUE-T scores and pinch forces significantly improved following home-based therapy (Δ 2.2 ± 4.1, p=0.025 and Δ 6.9N ± 15.5, p=0.020, respectively). Compliance with the prescribed therapy at-home was high and mirrored in-clinic therapy dosages, with participants completing 12.3 ± 2.9 sessions.
Conclusions:
Clinic and home-based ARCEX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.