Using Transcutaneous Spinal Cord Stimulation to stabilize blood pressure after spinal cord injury
Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
This study is testing whether a new method using Transcutaneous Spinal Cord Stimulation can help stabilize blood pressure in people with recent spinal cord injuries during their rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05305118 on ClinicalTrials.gov |
What this trial studies
This project investigates a novel non-pharmacologic approach to stabilize blood pressure during inpatient rehabilitation for individuals with acute spinal cord injury (SCI). The study focuses on Transcutaneous Spinal Cord Stimulation (TSCS), which can be rapidly activated and used alongside physical therapy. Researchers aim to determine the safety and feasibility of TSCS in preventing blood pressure instability, which is a common issue following SCI. By developing a standardized protocol for TSCS application, the study seeks to enhance rehabilitation outcomes for patients with unstable blood pressure.
Who should consider this trial
Good fit: Ideal candidates are newly injured patients with spinal cord injuries who are experiencing blood pressure instability and are between the ages of 18-89.
Not a fit: Patients who do not have unstable blood pressure or those who are not newly injured may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve rehabilitation outcomes for patients with acute spinal cord injuries by stabilizing their blood pressure.
How similar studies have performed: While the use of TSCS is a novel approach in this context, similar neuromodulation techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period * Meet the following Model Systems entry criteria with evidence of BP instability * Exhibit one or more of the following: Resting hypotension - systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females; OH - fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position; BP instability - fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg within a single day during routine activities in the AIR setting. * Have trouble with your blood pressure as determined by your doctor. * Participants must be between the ages of 18-89 years old, experienced a spinal cord injury (SCI) within the past 30 days to 6 months, have sustained a SCI with temporary or permanent loss of sensory and/or motor function, and are an inpatient for acute SCI rehabilitation therapy at Mount Sinai. * You are not dependent on a ventilator at this time. * You do not have a history of implanted pacemaker/defibrillator or significant coronary artery disease. 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 As part of the feasibility assessment, the study team will document demographic and injury characteristics of eligible patients who refuse enrollment, as well as reasons for ineligibility among those who do not meet entrance criteria.
Where this trial is running
New York, New York
- Mount Sinai Spinal Cord Injury Model System — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jill Wecht, EdD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Genevieve Curtis
- Email: genevieve.curtis@mountsinai.org
- Phone: (617) 922-3141
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.