What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
1. What are the immediate effects of spinal cord transcutaneous stimulation on BP?
2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
Who Is on the Research Team?
Gail F Forrest, PhD
Principal Investigator
Kessler Foundation
Are You a Good Fit for This Trial?
This trial is for adults with spinal cord injury who have problems with low blood pressure or dizziness when standing up. People with certain heart, nerve, or spine conditions may also be eligible. Those with health issues that could make participation unsafe will not be included.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Spinal Stimulation
Trial Overview
Researchers are testing if a non-invasive treatment called transcutaneous spinal stimulation (applying mild electrical currents through the skin over the spine) can help control blood pressure in people with spinal cord injuries. The study includes tilt tests and multiple sessions of this stimulation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer. The study consists of: 1. Baseline assessments, including a tilt test and various cardiovascular assessments 2. Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response. 3. Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring 4. 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2) 5. Repeat baseline assessments
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kessler Foundation
Lead Sponsor
Montclair State University
Collaborator
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