Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Orthostatic Hypotension

In brief

The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.

Key facts

Study ID

NCT05960448

Run by

James J. Peters Veterans Affairs Medical Center

People needed

20

Starts

2023-07-30

Expected to finish

2026-07-30

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• James J Peters VAMC — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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