Using Transcutaneous Spinal Cord Stimulation to stabilize blood pressure after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Automated Non-Invasive Blood Pressure: Tracking Blood Pressure Changes Using SpO2 Data

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.