Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI) (NCT05731986)
Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
๐ฉบ Plain-English Summary (8th-Grade Level)
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. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90ยฐ and dropping the base of the bed by 90ยฐ from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Who can join: Review the eligibility criteria below.
Location: Kessler Foundation โ West Orange, New Jersey
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Kessler Foundation โ West Orange, New Jersey
๐ Contact the Study Coordinator
Phone: (973) 324-3557
Email: lmartinez@kesslerfoundation.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injuries
- Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury โ Montreal, Quebec
- Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity โ Philadelphia, Pennsylvania
- SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI โ Manhasset, New York
- Autologous Adipose Derived Mesenchymal Stem Cells for Spinal Cord Injury Patients โ Rochester, Minnesota
- Standing, Stepping and Voluntary Movement Spinal Cord Epidural Stimulation โ Louisville, Kentucky
- Acute Intermittent Hypoxia on Leg Function Following Spinal Cord Injury โ Cambridge, Massachusetts
Explore by condition: All Spinal Cord Injuries clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.