Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKessler Foundation

About this trial

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

Qualifiers

Individuals with a SCI ≥ 1 year after injury

Injury level ≥ T6 (thoracic level)

AIS grade A-C

Persistent hypotension (SBP < 90mmHg)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Tilt test with stimulation (real-time effects): Intervention 1
  • 20 sessions of stimulation (Intervention 2)

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kessler Foundation

Lead sponsor

Montclair State University

Collaborator