Study of ARC-IM Therapy Using Epidural Electrical Stimulation to Help People With Subacute or Chronic Spinal Cord Injury Improve Walking and Other Movements

What this Trial Is About

Researchers are evaluating ARC-IM Therapy, which uses epidural electrical stimulation, to support and promote the recovery of walking and other ambulatory functions in people with subacute and chronic spinal cord injuries. The study includes adults aged 18 to 65 who have sustained a traumatic spinal cord injury either less than 6 weeks ago subacute or more than 1 year ago chronic. The goal is to assess the safety and preliminary effectiveness of this device in improving mobility. All participants will receive the ARC-IM Therapy, which delivers electrical impulses to the lower spinal cord region to aid walking. The study groups are divided by injury timing one group with injuries less than 6 weeks old and another with injuries more than 1 year old. This device treatment will be monitored continuously throughout the study. Participants will undergo assessments including neurological classification, walking tests 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go, walking indexes, gait analysis, goal attainment, and balance scales at baseline and multiple intervals up to 42 weeks after surgery. Safety is closely monitored throughout the study, focusing on any serious or related adverse events from implantation until study end, which can last up to 6 years. Participants must attend all scheduled visits and comply with the study requirements.

ARC-IM Therapy To Support and Promote Recovery of Ambulatory Functions in People With Subacute and Chronic Spinal Cord Injury