Actively Recruiting
TSCS for Acute SCI
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-16
50
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
J
James J. Peters Veterans Affairs Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This project will focus on a novel approach to stabilizing blood pressure (BP) during inpatient rehabilitation after acute SCI. After SCI, people have unstable blood pressure, ranging from too low (orthostatic hypotension) to too high (autonomic dysreflexia). Unstable BP often interferes with performing effective physical rehabilitation after SCI. A critical need exists for the identification of safe, practical and effective treatment options that stabilize BP after traumatic SCI. Transcutaneous Spinal Cord Stimulation (TSCS) has several advantages over pharmacological approaches: (1) does not exacerbate polypharmacy, (2) can be activated/deactivated rapidly, and (3) can be applied in synergy with physical exercise. The study team is asking the key question: "What if applying TSCS earlier after injury could prevent the development of BP instability?" To facilitate adoption of TSCS for widespread clinical use, the study team plans to map and develop a parameter configuration that will result in an easy to follow algorithm to maximize individual benefits, while minimizing the burden on healthcare professionals. This project will provide the foundational evidence to support the feasible and safe application of TSCS in the newly injured population, thereby overcoming barriers to engagement in prescribed inpatient rehabilitation regimens that are imposed by BP instability.
CONDITIONS
Official Title
TSCS for Acute SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly injured patients with spinal cord injury admitted during the 42-month recruitment period
- Meet Model Systems entry criteria with evidence of blood pressure instability
- Have resting hypotension (systolic BP ≤110 mmHg for males or ≤100 mmHg for females)
- Experience orthostatic hypotension (fall in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg within 10 minutes of standing)
- Show blood pressure fluctuations (systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg) within a single day during routine activities
- Have trouble with blood pressure as determined by a doctor
- Are between 18 and 89 years old
- Experienced spinal cord injury within the past 30 days to 6 months
- Have sustained SCI with temporary or permanent loss of sensory and/or motor function
- Are inpatients for acute SCI rehabilitation therapy at Mount Sinai
- Are not dependent on a ventilator
- Do not have a history of implanted pacemaker/defibrillator or significant coronary artery disease
You will not qualify if you...
- Implanted brain, spine, or nerve stimulators, cochlear implants, cardiac pacemaker/defibrillator, or intracardiac lines
- Open skin lesions on or near electrode placement sites (neck, upper back)
- Significant coronary artery or cardiac conduction disease
- Recent history of myocardial infarction
- Insufficient mental capacity to understand and provide consent independently
- Pregnancy
- Cancer
- Deemed unsuitable by the study physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Spinal Cord Injury Model System
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Genevieve Curtis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here