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

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study

Who can join

Ages 18 to 75 · All sexes

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:

  1. Baseline hypotension - resting supine or seated SBP \< 90mmHg;
  2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
  3. 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

About the study

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.

What is being tested

• Orthostatic challenge (diagnostic test)
• Biostim-5 transcutaneous spinal stimulation - Mapping (device)
• Biostim-5 transcutaneous spinal stimulation - "Optimal" testing (device)
• Biostim-5 transcutaneous spinal stimulation - "Sham" testing (device)

Sponsor: Kessler Foundation · Participants: 12 · Started: Dec 1, 2023

Contact the study team

• LeighAnn Martinez, BA · Phone: (973)324-3557

Official record on ClinicalTrials.gov — NCT05731986

Locations in the U.S.

Conditions

• Spinal Cord Injuries
• Spinal Cord Diseases
• Nervous System Trauma
• Neurologic Diseases
• Low Blood Pressure
• Orthostatic Hypotension
• Cardiovascular Disease

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.