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TSCS for Acute SCI
Sponsor: Icahn School of Medicine at Mount Sinai
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 (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.
Official title: Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-01-01
Completion Date
2027-10-01
Last Updated
2025-04-16
Healthy Volunteers
No
Interventions
TSCS Mapping
Prior to TSCS Intervention, participants will undergo TSCS Mapping. Electrode location, pulse frequency will be maintained while the stimulation intensity is ramped from 10 to 200 mA. Brachial blood pressures and symptoms will be monitored and recorded at each ramping interval and will continuously monitor and record beat-to-beat heart rate and blood pressures to determine the optimal site and frequency for further TSCS intervention TSCS electrodes will be placed at two vertebral levels in the and back and pulse frequency will be set at 30 to 240 Hz to determine the optimal site and frequency for further TSCS intervention.
Transcutaneous spinal cord stimulation
TSCS will be used as an adjunct intervention to promote blood pressure stability in conjunction with daily physical and occupational therapy in the inpatient rehabilitation gym. Stimulation will be added to therapy 3-5 times per week as needed for the duration of inpatient hospitalization following SCI. TSCS stimulation will be delivered using Digitimer DS7A, DS8R stimulators and Chattanooga Continuum (DS7A has FDA 510(k) clearance #K051357; Chattanooga Continuum is a Class 2 device).
Locations (1)
Mount Sinai Spinal Cord Injury Model System
New York, New York, United States