Intelligent Spine Interface, Clinical (ISI-C)

This research study is being done to test a new device developed for spinal cord injury (SCI) patients. The purpose of this study is to collect data on how the nervous system signals travel within the spinal cord of SCI patients. Once the investigators understand that, they hope to develop a device that may help rehabilitation of SCI patients so that they can regain function in their lower limbs. This study involves some imaging studies (e.g. X-rays etc.), surgical implantation of a portion of the electrical stimulation device, various assessments of body function (e.g. balance, movement, gait), and physical rehabilitation procedures. What is new and experimental is the stimulation/sensing device (Intelligent Spine Interface - Commercial, ISI-C) that will be implanted.

NCT Number	NCT04302259
Lead Sponsor	Rhode Island Hospital Collaborators: US Department of Veterans Affairs, Brown University, Intel Corporation
Conditions	Spinal Cord Injury
Enrollment	3 participants
Start Date	2021-09-01
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-14