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

Cardiovascular Diseases Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Cardiovascular (CV) control in persons with a high level (thoracic level T6 or above) spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Orthostatic hypotension (OH), a significant decrease in blood pressure (BP) when moving from lying flat (supine) to an upright position, appears early after injury and is frequently accompanied by dizziness, weakness, fatigue, and even syncope. In the long term, while symptoms are typically diminished, it still clinically occurs in 50% of individuals with a cervical injury. The physical, social, and emotional consequences of OH pose a major issue. Moreover, BP instability is associated with a decline in CV health and somewhat accounts for the 3 to 4-fold increased risk for stroke and heart disease in this clinical population.

In recent years, epidural spinal cord stimulation has been explored with promising results as a potential treatment for CV dysfunction. Spinal cord transcutaneous stimulation (scTS) represents an alternate approach, with the potential to benefit more people with fewer risks. Only one study thus far successfully applied scTS to restore CV function and resolve orthostatic symptoms following SCI, with stimulation applied at one thoracic location.

The objective of this study is to investigate the effect of scTS on BP in individuals with chronic SCI who experience OH. Stimulation sites and parameters that consistently increase and stabilize systolic BP within the range of 110-120 mmHg, during an orthostatic provocation (a 70° tilt-test), will be sought. The investigators will also evaluate whether there is any change in the BP response following repeated stimulation sessions. This project will provide the foundational evidence to use scTS to improve autonomic function in various SCI populations and help overcome barriers to engagement in activity and participation imposed by autonomic dysfunction. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05725499
• Study type: Interventional
• Source: Kessler Foundation
• Contact: LeighAnn Martinez, BA
• Phone: (973)324-3557
• Email: lmartinez@kesslerfoundation.org
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Completion date: March 2024