RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Current forms of pharmacologic and non-pharmacologic treatments for hypotension and orthostatic hypotension (OH) remain inadequate during acute inpatient rehabilitation (AIR) following a traumatic spinal cord injury (SCI). A critical need exists for the identification of safe, practical, and effective treatment options that stabilize blood pressure (BP) after traumatic SCI. Recent published evidence suggests that transcutaneous Spinal Cord Stimulation (TSCS) can be used to raise seated BP, and mitigate the falls in BP during orthostatic repositioning in individuals with chronic SCI. This site-specific project will focus on the use of TSCS to stabilizing seated BP and mitigate the fall in BP during orthostatic repositioning during AIR following traumatic SCI.

Official Title

Safety, Feasibility, and Efficacy of Transcutaneous Spinal Cord Stimulation on Stabilizing Blood Pressure for Acute Inpatients With Spinal Cord Injury

Quick Facts

Study Start:2022-01-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06000592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Newly injured patients with traumatic SCI
  2. * Admitted to Acute Inpatient Rehabilitation at Mount Sinai
  3. * Within one year of SCI
  4. * Seated hypotension (systolic BP ≤ 110 mmHg for males or ≤ 100 mmHg for females)
  5. * 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)
  6. * Daily fluctuation in systolic BP ≥ 20 mmHg and/or fluctuation in diastolic BP ≥ 10 mmHg
  7. * At least 14 years old
  1. * Implanted brain/spine/nerve stimulators
  2. * Cochlear implants
  3. * Cardiac pacemaker/defibrillator, or intracardiac lines
  4. * Open skin lesions on or near the electrode placement sites (neck, upper back)
  5. * Significant coronary artery or cardiac conduction disease
  6. * Recent history of myocardial infarction
  7. * Insufficient mental capacity to understand and independently provide consent
  8. * Pregnancy
  9. * Cancer
  10. * Deemed unsuitable by study physician

Contacts and Locations

Study Contact

Jorge Chavez, BS
CONTACT
(914)343-0713
jorge.chavez2@mountsinai.org
Jill M Wecht, EdD
CONTACT
(718)584-9000
jm.wecht@va.gov

Principal Investigator

Thomas N Bryce, MD
STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

The Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Jill M. Wecht, Ed.D.

  • Thomas N Bryce, MD, STUDY_DIRECTOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-01-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Spinal Cord Injury
  • Spinal Cord Injuries
  • Neuromodulation
  • Traumatic Spinal Cord Injury
  • Spinal Cord Stimulation
  • SCI - Spinal Cord Injury
  • Blood Pressure
  • Blood Pressure Disorders