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New treatment option for Spinal Cord Injuries (SCI)
Official title Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
ClinicalTrials.gov ID: NCT06841198
What this study is testing
- What it's testing
- The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure. The main questions are: How does stimulation affect blood pressure over the year?
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. Healthy volunteers may be eligible.
You may be able to join if
- For the main study:
- Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Between 18-75 years old
- 7-50 days after injury
- Injury level ≥ T6 (a cervical or a high-level chest injury)
You likely can't join if
- A ventilator is needed for breathing.
- Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
- There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
- A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
- There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or...
- There is a history of seizures.
See the full eligibility criteria
- For the main study:
- Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
- Between 18-75 years old
- 7-50 days after injury
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- Individuals experiencing low blood pressure after the injury
- American Spinal Injury Association Impairment Scale (AIS) A or B
- A ventilator is needed for breathing.
- Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
- There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
- A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
- There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might...
- There is a history of seizures.
- Pregnancy. For the spin-off study ice-water vs ice-wrap test (see description in study arms): \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Inclusion: Age...
- Injury sustained more than 6 months ago
- Injury level ≥ T6 (a cervical or a high-level chest injury)
- American spinal injury association impairment scale (AIS) A - D Exclusion: Foot lesions, uses a ventilator, devices such as brain/spine/nerve stimulators, significant or recent cardiovascular disease, known infection in...
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. Healthy volunteers may be eligible. 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.