Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Launched by JAMES J. PETERS VETERANS AFFAIRS MEDICAL CENTER · Jul 17, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how a treatment called transcutaneous spinal cord stimulation (TSCS) can help people with spinal cord injuries manage certain health issues, specifically orthostatic hypotension, which is a condition that can cause dizziness when standing up. The study aims to see if TSCS can improve exercise performance and how well the body regulates temperature during physical activity and in cold conditions. Participants will experience both the active TSCS and a placebo (sham) version while using an arm bicycle or sitting in a cold room, allowing researchers to compare the effects of each.

To participate, you need to be at least 18 years old and have a spinal cord injury located between the cervical vertebrae C3 and T6 that happened more than a year ago. You must also have stable medications for at least 30 days and have completed a prior related study. However, if you have certain health conditions such as diabetes, heart disease, or neurological disorders, you may not be eligible. While this study is important, please note that it is not expected to provide long-term benefits. Participants will receive guidance throughout the study, and their experiences will help researchers understand the potential of TSCS for improving health in the spinal cord injury community.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • You are above the age of 18 years old
• • You have an SCI between C3-T6
• • You have been injured longer than 1 year
• • You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"
• • You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
• • Your prescription medications have not changed for at least 30 days
• Exclusion Criteria:
• • You have a history of seizures
• • You have an acute illness or infection
• • You have diabetes
• • You have untreated thyroid disease
• • You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)
• • You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)
• • You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment
• • You have a present or history of a psychological disorder
• • You have contraindications to electricity over your spine
• • You are dependent on a ventilator to breathe or have an open tracheostomy site
• • You have a recent history of substance abuse (within the past 3 months)
• • You have open wounds over the spine at the level targeted for stimulation
• • You are pregnant