Evaluating Blood Pressure and Autonomic Function Changes in the First Year After Spinal Cord Injury Using Spinal Stimulation

What this Trial Is About

Researchers are investigating cardiovascular function changes during the first year after a spinal cord injury SCI, focusing on how blood pressure responds to spinal cord transcutaneous stimulation scTS. The study targets individuals with recent SCI who have low blood pressure and orthostatic hypotension, aiming to determine the best timing to start scTS and understand how cardiovascular activation evolves over time. The study includes both inpatient and outpatient phases, with detailed autonomic function testing to assess blood pressure and autonomic responses. Participants receive scTS using a 5-channel electrical stimulator starting shortly after injury, with sessions occurring regularly over one year. The inpatient phase involves 5-11 sessions including autonomic questionnaires, 24-hour blood pressure monitoring, cold pressor tests, and tilt tests with and without stimulation, along with 2-3 days of stimulation mapping. The outpatient phase includes 15-18 sessions with monthly mapping and autonomic assessments, plus comprehensive testing at 6, 9, and 12 months post-injury. A supplementary spin-off study compares two cooling methods ice-water immersion and ice-wrap in different body positions to find the most consistent blood pressure response. Participants undergo multiple assessments such as 70-degree tilt tests, cold pressor tests, autonomic dysfunction questionnaires, and 24-hour ambulatory blood pressure monitoring at regular intervals throughout the year. Blood pressure and electromyography are monitored continuously during stimulation to maintain target blood pressure levels. The study tracks blood pressure response to stimulation, orthostatic hypotension symptoms, and autonomic dysfunction development. The total study duration covers about 20-29 sessions from inpatient stay to outpatient follow-up extending up to one year post-injury.

Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury