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NCT07674511
Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury
Conditions: Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System, Central Nervous System Disease, Nervous System Diseases, Blood Pressure
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Kessler Foundation
Location: Kessler Foundation West Orange New Jersey
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?
Eligibility Criteria
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-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
* History of seizures
* pregnancy
* Insufficient mental capacity to understand and independently provide consent
* Deemed unsuitable by the study physician
Source: ClinicalTrials.gov (NCT07674511). StuddyBuddy aggregates publicly available trial information.