Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05725499

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

Led by Kessler Foundation · Updated on 2025-09-02

5

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spinal cord injury for greater than or equal to 6 months
  • Injury level at or above thoracic level T6
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
  • Exhibits at least one hypotensive symptom: baseline resting systolic blood pressure (SBP) below 90 mmHg, or a drop of SBP by 20 mmHg or more within 5 minutes of sitting up, or symptoms of orthostasis with SBP below 90 mmHg when moving from lying down to sitting
Not Eligible

You will not qualify if you...

  • Current illness such as infection, pressure injury interfering with intervention, or recent deep vein thrombosis/pulmonary embolism diagnosis
  • Ventilator-dependent
  • History of implanted brain, spine, or nerve stimulators
  • Cardiac pacemaker, defibrillator, or intra-cardiac lines
  • Significant coronary artery or cardiac conduction disease, or recent myocardial infarction
  • Insufficient mental capacity to understand and provide consent
  • Pregnancy
  • Cancer
  • Deemed unsuitable by 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

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Research Team

L

LeighAnn Martinez, BA

CONTACT

E

Einat Engel-Haber, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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