The Safety, feasibility, and efficacy of transcutaneous spinal cord stimulation on stabilizing blood pressure for acute inpatients with spinal cord injury is part of the Mount Sinai Spinal Cord Injury Model System. Participants in this research study can participate in this specific study if they qualify for the MAIN STUDY.
Following SCI, patients often lose their ability to regulate their blood pressure. Many patients experience dizziness, nausea and may pass-out during therapy because of hypotension (low resting blood pressure) and orthostatic hypotension (falls in blood pressure when sitting-up or standing). This experience can prevent these individuals from adhering to therapy which can in turn limit long-term outcomes. Ensuring that newly injured patients with SCI can follow through on their prescribed therapy program is therefore essential. Spinal cord stimulation (SCS) is a form of therapy that may improve blood pressure in patients with SCI, thus allowing for better participation in prescribed therapy. The goal of this study is to determine the safety and feasibility of using transcutaneous spinal cord stimulation (TSCS), a non-invasive form of SCS, that is applied to the skin over the spine, to stabilize blood pressure within a target range during acute inpatient rehabilitation in newly injured patients with traumatic SCI. We define the target range as a systolic blood pressure between 110-130 mmHg in males and 100-130 mmHg in females. Participants will receive stimulation in conjunction with their daily therapy sessions. To assess safety, we will document levels of blood pressure, pain, discomfort, and skin integrity after application of TSCS. To evaluate the feasibility, we will develop a standard mapping algorithm designed to be easily followed by clinical therapists. We will determine the immediate effect of TSCS to increase blood pressure, improve brain blood flow and reduce symptoms of orthostatic intolerance after a bedside sit-up test. We will also look at the effect of TSCS on cumulative blood pressure stability, muscle strength, and adherence to prescribed therapy program during acute inpatient rehabilitation.
Dr. Thomas Bryce is the principal investigator of this project.