About this trial

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.

Eligibility criteria

Qualifiers

Spinal cord injury for greater than or equal to 6 months

Injury level ≥ T6 (thoracic level)

American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D

Baseline hypotension - resting supine or seated systolic blood pressure(SBP) < 90mmHg;

Disqualifiers

Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)

Ventilator-dependent

History of implanted brain/spine/nerve stimulators

Cardiac pacemaker/defibrillator or intra-cardiac lines

Trial design

Treatments tested in this trial

  • Biostim-5 transcutaneous spinal stimulator
  • Tilt-table orthostatic stress testing

Treatment groups

5 Participants
are divided into 1 treatment group

Locations

1
Kessler Foundation07052, West OrangeNew Jersey, United States

Sponsors and collaborators

Kessler Foundation

Lead sponsor