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

Description

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

Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System, Central Nervous System Diseases, Nervous System Diseases, Blood Pressure

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Study Overview

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Study Details

Study overview

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.

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury

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

Condition
Spinal Cord Injuries
Intervention / Treatment

-

Contacts and Locations

West Orange

Kessler Foundation, West Orange, New Jersey, United States, 07052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Exhibits at least one of the following hypotensive symptoms:
  • 1. Baseline hypotension - resting supine or seated systolic blood pressure(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
  • * 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
  • * Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
  • * Insufficient mental capacity to understand and independently provide consent
  • * Pregnancy
  • * Cancer
  • * Deemed unsuitable by study physician

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kessler Foundation,

Gail F Forrest, Phd, PRINCIPAL_INVESTIGATOR, Kessler Foundation

Study Record Dates

2024-03