Status:
RECRUITING
TSCS for Acute SCI
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
James J. Peters Veterans Affairs Medical Center
Conditions:
Acute Spinal Cord Injury
Blood Pressure
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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 (or...
Detailed Description
This site-specific project will focus on a novel non-pharmacologic approach to stabilizing blood pressure (BP) during acute inpatient rehabilitation after acute traumatic spinal cord injury (SCI). Cur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05305118
Start Date
January 1 2022
End Date
October 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
Mount Sinai Spinal Cord Injury Model System
New York, New York, United States, 10029