The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
Individuals with a SCI ≥ 1 year after injury
Injury level ≥ T6 (thoracic level)
AIS grade A-C
Persistent hypotension (SBP < 90mmHg)
Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
Ventilator-dependent
History of implanted brain/spine/nerve stimulators
Cardiac pacemaker/defibrillator or intra-cardiac lines
Single group
Tilt test with stimulation (real-time effects): Intervention 1
DeviceWhile lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.
20 sessions of stimulation (Intervention 2)
DeviceParticipants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
Systolic blood pressure
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
Systolic blood pressure
changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation
duration in tilt test
how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table)
Orthostatic symptoms questionnaire
A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity.
24-hour ABPM OH events - taken at home
Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities and their time-points. Conducted before, halfway through, and after the intervention
Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores
24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
Montclair State University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
