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Official title Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
ClinicalTrials.gov ID: NCT05960448
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- You have an American Spinal Injury Association injury classification scale (AIS) A, B, C
You likely can't join 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,)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.