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Procedure
TSCS for Spinal Cord Injury Blood Pressure Control
N/A
Recruiting
Research Sponsored by Jill M. Wecht, Ed.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up acute inpatient rehabilitation following sci (up to 4 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial proposes a novel approach to stabilizing BP in people with acute traumatic SCI using Transcutaneous Spinal Cord Stimulation (TSCS). This could help prevent BP instability and make it easier for healthcare professionals to provide treatment.
Who is the study for?
This trial is for acute inpatients with a traumatic spinal cord injury (SCI) within one year of the injury, experiencing low blood pressure related issues. They must be at least 14 years old and admitted to Acute Inpatient Rehabilitation at Mount Sinai. Exclusions include heart disease, recent heart attack, cancer, certain implants like pacemakers or cochlear implants, open skin lesions near electrode sites, pregnancy, or inability to consent.
What is being tested?
The trial tests Transcutaneous Spinal Cord Stimulation (TSCS), a non-drug method aimed at stabilizing blood pressure after SCI. It's designed as an alternative to epidural stimulation and can be quickly turned on/off and used alongside physical exercise. The goal is to create a standard treatment algorithm for clinical use.
What are the potential side effects?
While specific side effects are not listed here, TSCS generally has fewer risks compared to invasive procedures like epidural SCS since it's non-pharmacological and applied externally.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ acute inpatient rehabilitation following sci (up to 4 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~acute inpatient rehabilitation following sci (up to 4 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The efficacy (#1) of TSCS to improve autonomic control following acute SCI.
The safety (#1) of TSCS to improve autonomic control following acute SCI.
The safety (#2) of TSCS to improve autonomic control following acute SCI.
Secondary study objectives
The efficacy (#2) of TSCS to improve autonomic control following acute SCI.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: transcutaneous spinal stimulationExperimental Treatment1 Intervention
Transcutaneous spinal cord stimulation (TSCS) protocol to stabilize seated systolic blood pressure in newly injured patients with spinal cord injury and to test the ability of TSCS to reduce the fall in blood pressure when these patients are moved from the supine to the seated position.
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Who is running the clinical trial?
Jill M. Wecht, Ed.D.Lead Sponsor
Icahn School of Medicine at Mount SinaiOTHER
913 Previous Clinical Trials
572,751 Total Patients Enrolled
Thomas N Bryce, MDStudy DirectorIcahn School of Medicine at Mount Sinai