Abstract Details

Title Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy) Is Safe and Effective at Improving Upper Extremity Function Following Spinal Cord Injury

Topic Neuro-rehabilitation

Presentation(s) P7 - Poster Session 7 (11:45 AM-12:45 PM)

Poster/Presentation
Number 11-001

Objective To determine the safety and effectiveness of ARC^EX Therapy delivered in the clinic and home setting.

Background Cervical SCI leads to upper extremity (UE) impairment significantly altering quality of life. ARC^EX 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 ARC^EX Therapy, with stimulation delivered over the cervical spinal cord. Within 12 months of completion of in-clinic ARC^EX 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 ARC^EX Therapy phase of the Up-LIFT Trial. Similar effectiveness outcomes were obtained during the LIFT Home Trial (excluding UEMS).

Results No SAEs related to ARC^EX Therapy were reported in any of the individuals who participated in clinic or home-based therapy. Of sixty participants who completed the in-clinic ARC^EX 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 ARC^EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.

Authors/Disclosures
Candace Tefertiller (Craig Hospital) PRESENTER	Candace Tefertiller has received personal compensation in the range of $0-$499 for serving as a Consultant for Onward Medical.
Randy Trumbower (Harvard Medical School)	Randy Trumbower has nothing to disclose.
Leslie Morse	No disclosure on file
Ilse Nes (Sint Maartenskliniek)	No disclosure on file
Sukhvinder Kalsi-Ryan (KITE Research Institute)	No disclosure on file
Mariel Purcell	No disclosure on file
Thomas Janssen	No disclosure on file
Andrei Krassioukov (ICORD UBC)	No disclosure on file
Kristin Zhao (Mayo Clinic)	No disclosure on file
James Guest, MD (Neurological Surgery, Miller School of Medicine)	James Guest, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. The institution of James Guest, MD has received research support from NINDS. The institution of James Guest, MD has received research support from US Department of Defense.
Ralph Marino	No disclosure on file
Lynda Murray (The Icahn School of Medicine at Mount Sinai)	No disclosure on file
Jill Wecht (James J Peters VA Medical Center)	No disclosure on file
Markus Rieger	No disclosure on file
Jared Pradarelli (OWARD Medical)	No disclosure on file
Jenny Suggitt (ONWARD Medical)	No disclosure on file
Amanda Turner (ONWARD)	No disclosure on file
Kristen Gelenitis (ONWARD Medical)	Kristen Gelenitis has received personal compensation for serving as an employee of ONWARD Medical. Kristen Gelenitis has or had stock in ONWARD Medical.
Jessica D'Amico	Jessica D'Amico has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Onward Medical Inc.
Chet Moritz	Chet Moritz has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Onward Medical. Chet Moritz has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Fraser, Watson & Croutch. Chet Moritz has received intellectual property interests from a discovery or technology relating to health care.
Edelle Field-Fote (Shepherd Center)	Edelle Field-Fote has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Onward Medical. The institution of Edelle Field-Fote has received research support from National Institutes of Health. The institution of Edelle Field-Fote has received research support from National Institute on Disability Independent Living and Rehabilitation Research. Edelle Field-Fote has received publishing royalties from a publication relating to health care.

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