Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects
Kessler Foundation
Summary
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?
Description
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Individuals with a SCI ≥ 1 year after injury * Injury level ≥ T6 (thoracic level) * AIS grade A-C * Cardiovascular dysfunction characterized by one or more of the following: 1. Persistent hypotension (SBP \< 90mmHg) 2. Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning). Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH. Exclusion Criteria: * Current illness (e.g., infection, a pressure injury that might interfere with the intervention) * Ventilator-dep…
Interventions
- DeviceTilt test with stimulation (real-time effects): Intervention 1
While 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.
- Device20 sessions of stimulation (Intervention 2)
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
Location
- Kessler FoundationWest Orange, New Jersey