The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.
The main questions it aims to answer are:
1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?
Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
7-30 days after injury
Injury level ≥T2 (thoracic level)
American Spinal Injury Association Impairment Scale (AIS) A-C
Baseline hypotension - resting supine or seated SBP < 90mmHg;
Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
Ventilator-dependent
History of implanted brain/spine/nerve stimulators
Cardiac pacemaker/defibrillator or intra-cardiac lines
Crossover
Orthostatic challenge
Diagnostic testDesigned to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee. This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation.
Biostim-5 transcutaneous spinal stimulation - Mapping
DeviceTranscutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz.
Biostim-5 transcutaneous spinal stimulation - "Optimal" testing
DeviceBased on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg).
Biostim-5 transcutaneous spinal stimulation - "Sham" testing
DeviceBased on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.
Optimal stimulation sites
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
Optimal stimulation frequency
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP
A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation.
Change in Orthostatic symptoms when stimulation is applied
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation.
Numeric Rating Scale (NRS) for pain
Adverse effects will be recorded to assess the safety of stimulation. A numerical scale of 0 to 10 (with 10 meaning the worst pain) will be used to monitor any pain symptoms associated with the stimulation
Skin integrity assessment
Adverse effects will be recorded to assess the safety of stimulation. Skin integrity (skin irritation or breakdown caused by electrodes, wires or adhesive tape) will be assessed on a daily basis
Feasibility of applying scTS in inpatient settings - compliance
The ratio of total number of completed sessions divided by the number of sessions initially planned.
Feasibility of applying scTS in inpatient settings - session duration
The length of time of each session and total length will be recorded.
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