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Not Yet Recruiting NCT05725499

The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)

Conditions: Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System, Central Nervous System Diseases, Nervous System Diseases, Blood Pressure

Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 5
Sponsor: Kessler Foundation

Location: United States

Summary

This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).The main questions it aims to answer are:What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

Eligibility Criteria

Inclusion Criteria:Spinal cord injury for greater than or equal to 6 monthsInjury level ≥ T6 (thoracic level)American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-DExhibits at least one of the following hypotensive symptoms:Baseline hypotension - resting supine or seated systolic blood pressure(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 sittingExclusion Criteria:Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)Ventilator-dependentHistory of implanted brain/spine/nerve stimulatorsCardiac pacemaker/defibrillator or intra-cardiac linesSignificant coronary artery or cardiac conduction disease, a recent history of myocardial infarctionInsufficient mental capacity to understand and independently provide consentPregnancyCancerDeemed unsuitable by study physician

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05725499). StuddyBuddy aggregates publicly available trial information.