Using transcutaneous spinal cord stimulation to stabilize blood pressure in acute spinal cord injury patients
Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
This study is testing if a new method called transcutaneous spinal cord stimulation can help stabilize blood pressure in patients with recent spinal cord injuries during their rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 100 Years |
| Sex | All |
| Sponsor | James J. Peters Veterans Affairs Medical Center Federal |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06000592 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety, feasibility, and efficacy of transcutaneous spinal cord stimulation (TSCS) for stabilizing blood pressure in patients with acute spinal cord injuries during inpatient rehabilitation. It aims to address the inadequacies of current treatments for hypotension and orthostatic hypotension by exploring how TSCS can improve seated blood pressure and reduce blood pressure fluctuations during orthostatic challenges. The study will assess the tolerability of TSCS, monitor for any adverse effects such as skin burns, and evaluate its impact on symptoms of orthostatic intolerance. A key deliverable will be a standardized algorithm for the application of TSCS to enhance clinical utility in this patient population.
Who should consider this trial
Good fit: Ideal candidates include newly injured patients with traumatic spinal cord injuries who are admitted to acute inpatient rehabilitation and experience seated hypotension or orthostatic hypotension.
Not a fit: Patients with implanted stimulators, significant cardiac issues, or those who are pregnant or have cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective method for managing blood pressure in patients with acute spinal cord injuries.
How similar studies have performed: While the use of TSCS is a novel approach, previous studies have shown promise in its application for chronic spinal cord injury patients, indicating potential for success in this acute setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
New York, New York
- The Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Jorge Chavez, BS
- Email: jorge.chavez2@mountsinai.org
- Phone: (914)343-0713
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.