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New treatment option for Spinal Cord Injuries
Official title Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)
ClinicalTrials.gov ID: NCT05731986
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- 7-30 days after injury
- Injury level ≥T2 (thoracic level)
- American Spinal Injury Association Impairment Scale (AIS) A-C
- Exhibits at least one of the following hypotensive symptoms:
- Baseline hypotension - resting supine or seated SBP \< 90mmHg;
You likely can't join if
- Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the...
- 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
- Initiated on new cardiac medications within the past 5 days
See the full eligibility criteria
- 7-30 days after injury
- Injury level ≥T2 (thoracic level)
- American Spinal Injury Association Impairment Scale (AIS) A-C
- Exhibits at least one of the following hypotensive symptoms:
- Baseline hypotension - resting supine or seated 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 (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
- 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
- Initiated on new cardiac medications within the past 5 days
- 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
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.