Safety, Feasibility, and Efficacy of TSCS on Stabilizing Blood Pressure for Acute Inpatients With SCI

Launched by JILL M. WECHT, ED.D. · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called transcutaneous spinal cord stimulation (TSCS) to help stabilize blood pressure in patients who have suffered a traumatic spinal cord injury (SCI). When people with SCI are admitted to the hospital for rehabilitation, they often experience low blood pressure, especially when moving from sitting to standing. This can lead to dizziness or fainting. The study aims to see if TSCS can help improve blood pressure during these situations, making it safer for patients as they recover.

To participate in this trial, individuals must be newly injured patients with traumatic SCI, admitted to the Acute Inpatient Rehabilitation at Mount Sinai, and be at least 14 years old. They should also be experiencing low blood pressure or significant fluctuations in their blood pressure. However, certain conditions may exclude someone from participating, such as having implanted devices like pacemakers or recent heart problems. Participants in the trial can expect to receive the TSCS treatment and be monitored closely to see how it affects their blood pressure during rehabilitation. This study is currently recruiting and aims to find safer and more effective ways to manage blood pressure for those with acute spinal cord injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly injured patients with traumatic SCI
• • Admitted to Acute Inpatient Rehabilitation at Mount Sinai
• • Within one year of SCI
• • Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
• • Orthostatic hypotension (fall in systolic BP ≥ 20 mmHg and/or a fall in diastolic BP ≥ 10 mmHg within 10 minutes of assuming an upright position)
• • Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
• • At least 14 years old
• 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