New treatment option for Spinal Cord Injuries
Official title The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
ClinicalTrials.gov ID: NCT05725499
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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:
- Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
You likely can't join if
- 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
See the full 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:
- Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
- SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- West Orange, New Jersey, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Orange, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.