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New treatment option for Spinal Cord Injury
Official title Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
ClinicalTrials.gov ID: NCT07504055
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if non-invasive spinal cord stimulation intervention improves blood pressure regulation in individuals with chronic spinal cord injury. The main questions it aims to answer are: Can site specific spinal cord stimulation enhance blood pressure regulation?
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
- At least 18 years old,
- Stable medical condition,
- Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological...
- Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade "A," "B," or "C" above T1 spinal level...
- Sustained SCI at least 12 months prior to entering the study,
You likely can't join if
- Major pulmonary or cardiovascular disease unrelated to SCI,
- Ventilator dependence,
- Painful musculoskeletal dysfunction that might interfere with testing or stimulation,
- Unhealed fracture that might interfere with testing or stimulation,
- Unhealed contracture that might interfere with testing or stimulation,
- Unhealed pressure sore that might interfere with testing or stimulation,
See the full eligibility criteria
- At least 18 years old,
- Stable medical condition,
- Non-progression SCI (no negative change in the neurological level and motor-completeness assess during screening when compared to the neurological status assessed at 6-month period after injury or at least 6 months...
- Motor-complete SCI according to the American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade "A," "B," or "C" above T1 spinal level according to the ASIA International Standards for Neurological...
- Sustained SCI at least 12 months prior to entering the study,
- Evidence of symptomatic hypotension as determined by a total score \>0 on the Orthostatic Hypotension Symptom Assessment (OSHA),
- Normal renal function as defined by eGFR \> 59 ml/min/1.73, creatinine value within the range of 0.6-1.2 mg/dl, and BUN values within the range of 7-18 mg/dl,
- Competent to give informed consent for the research protocol,
- Able to understand instructions.
- Major pulmonary or cardiovascular disease unrelated to SCI,
- Ventilator dependence,
- Painful musculoskeletal dysfunction that might interfere with testing or stimulation,
- Unhealed fracture that might interfere with testing or stimulation,
- Unhealed contracture that might interfere with testing or stimulation,
- Unhealed pressure sore that might interfere with testing or stimulation,
- Untreated clinically significant depression or psychiatric disorders,
- Ongoing drug abuse,
- Malignancy ,
- Class III obesity (BMI \>40) and at least one co-morbidity thereof: a) Type 2 diabetes as defined by ≥6.5% level on two separate glycated hemoglobin (A1C) tests, b) hypertension as defined by consistent blood pressure...
- Acute or chronic obstructive deep vein thrombosis,
- Secondary hypotension unrelated to SCI (anemia, hypervolemia, endocrine and neurological diseases),
- Major esophageal/gastrointestinal problem,
- Currently pregnant (females of childbearing potential only),
- Other major medical illness contraindicated for testing or stimulation.
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, 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 Louisville, Kentucky, 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.