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Tests treatment safety and results for Acute Spinal Cord Injury
Official title Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI
ClinicalTrials.gov ID: NCT06000592
What this study is testing
- What it's testing
- Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 100
You may be able to join if
- Newly injured patients with traumatic SCI
- Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- Within one year of SCI
- Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
- Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
You likely can't join if
- Implanted brain/spine/nerve stimulators
- Cochlear implants
- Cardiac pacemaker/defibrillator, or intracardiac lines
- Open skin lesions on or near the electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
- Recent history of myocardial infarction
See the full eligibility criteria
- Newly injured patients with traumatic SCI
- Admitted to Acute Inpatient Rehabilitation at Mount Sinai
- Within one year of SCI
- Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
- Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
- Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
- At least 14 years old
- Implanted brain/spine/nerve stimulators
- Cochlear implants
- Cardiac pacemaker/defibrillator, or intracardiac lines
- Open skin lesions on or near the electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
- 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
- New York, New York, 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, 14 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.