Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury

What this Trial Is About

Researchers are studying the use of transcutaneous spinal cord stimulation (TSCS) to stabilize blood pressure in people with acute spinal cord injury (SCI) during inpatient rehabilitation. The study aims to find safe and practical treatments to manage hypotension and orthostatic hypotension, conditions that cause low blood pressure and are common after SCI. TSCS may offer advantages over current drug treatments by being quickly adjustable and usable alongside physical exercise, potentially improving care during early rehabilitation. The study involves applying TSCS to newly injured patients with SCI who experience low seated blood pressure and drops in blood pressure when moving to an upright position. TSCS is delivered through a device called Digitimer, targeting the spinal cord to raise seated systolic blood pressure and reduce blood pressure falls during position changes. The research will test the safety and tolerability of TSCS, including monitoring pain and skin reactions near electrode sites, while developing an easy-to-follow protocol for wider clinical use. Participants will undergo acute inpatient rehabilitation lasting up to four months following their SCI. During this time, researchers will monitor blood pressure control, symptoms of orthostatic intolerance, and any adverse effects. Assessments include measuring blood pressure changes with posture shifts and daily fluctuations. The study will also evaluate the overall safety of TSCS and its impact on autonomic nervous system function. This research aims to support safe and effective use of TSCS to improve rehabilitation outcomes for people with new spinal cord injuries.

Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI