Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI) (SCI)
Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Transcutaneous Spinal Cord Stimulation, Spinal stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation, Acute spinal cord injury, Hypotension, Acute inpatient rehabilitation
Eligibility Criteria
Inclusion Criteria: 7-30 days after injury Injury level ≥T2 (thoracic level) American Spinal Injury Association Impairment Scale (AIS) A-C Exhibits at least one of the following hypotensive symptoms: Baseline hypotension - resting supine or seated SBP < 90mmHg; SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position; Symptoms of orthostasis with a drop of SBP (<90mmHg) from supine to sitting. Exclusion Criteria: 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 Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction Initiated on new cardiac medications within the past 5 days Insufficient mental capacity to understand and independently provide consent Pregnancy Cancer Deemed unsuitable by study physician
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Optimal stimulation (for a blood pressure response)
Sham stimulation
Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure.
Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well.