Actively Recruiting
Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)
Led by Kessler Foundation · Updated on 2025-09-02
12
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Injury occurred 7 to 30 days before enrollment
- Spinal cord injury level at or below thoracic level 2 (T2)
- American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C
- Exhibits at least one hypotensive symptom: resting systolic blood pressure below 90 mmHg, a drop of 20 mmHg or more in systolic blood pressure within 5 minutes of sitting up, or symptoms of orthostasis with systolic blood pressure below 90 mmHg when moving from lying down to sitting
You will not qualify if you...
- Current illness or infection such as recent deep vein thrombosis or pulmonary embolism
- Ventilator-dependent
- History of implanted brain, spine, or nerve stimulators
- Presence of cardiac pacemaker, defibrillator, or intra-cardiac lines
- Significant coronary artery or cardiac conduction disease or recent heart attack
- Started new cardiac medications within the past 5 days
- Unable to provide informed consent independently due to mental capacity
- Pregnancy
- Cancer
- Deemed unsuitable to participate by the study physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
L
LeighAnn Martinez, BA
CONTACT
E
Einat Engel-Haber, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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