TSCS for Acute SCI

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method called Transcutaneous Spinal Cord Stimulation (TSCS) to help stabilize blood pressure in patients who have recently experienced a spinal cord injury (SCI). After an SCI, many patients struggle with unstable blood pressure, which can be too low or too high, making it harder to participate in rehabilitation activities. The researchers want to find out if using TSCS early on can help prevent these blood pressure problems, allowing patients to engage more effectively in their recovery.

To be eligible for the trial, participants must be between 18 and 89 years old, have experienced a spinal cord injury within the last 30 days to 6 months, and currently be an inpatient receiving rehabilitation therapy. They should also have issues with blood pressure that have been identified by their doctor. Participants will receive TSCS treatment, and the study team will monitor how it affects their blood pressure and rehabilitation progress. This research aims to provide valuable information that could lead to better care and recovery options for people with acute spinal cord injuries.

Gender

ALL

Eligibility 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.