Up-LIFT Study Version C
Research type
Research Study
Full title
Clinical assessment of upper extremity performance in individuals with spinal cord injury using the LIFT System to deliver non-invasive electrical spinal stimulation (ARC Therapy)
IRAS ID
290771
Contact name
Margaret A Purcell
Contact email
Sponsor organisation
GTX Medical, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Research Summary
This project involves studying an investigational device, LIFT System, as a possible treatment for loss or reduced use of the arms and hands caused by spinal cord injury (SCI). The study will involve occupational therapy sessions which consist of hand and arm exercises along with the non-invasive electrical spinal stimulation (ARC) therapy delivered by the LIFT System. ARC therapy delivers electrical stimulation through the gel electrodes placed on the skin. The electrical energy passes through the skin and the tissue below down to the nerves. The type of electrical energy being used is thought to enable the spinal cord and nerves to become active again after an injury or illness that caused paralysis.
Summary of Results
The Up-LIFT Study enrolled 65 participants at 14 sites in the United States, Canada, the United Kingdom and the Netherlands, and demonstrated statistically significant and clinically meaningful improvement in upper extremity strength and function after a short series of in-clinic therapy sessions using the LIFT System. These gains were notable in contrast to the limits of standard of care treatments also evaluated in the study. No serious device related adverse events were reported in the study.
REC name
West of Scotland REC 4
REC reference
21/WS/0001
Date of REC Opinion
2 Mar 2021
REC opinion
Further Information Favourable Opinion