RECRUITING

TSCS for Acute 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

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

Quick Facts

Study Start:2022-03-18
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05305118

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:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All newly injured patients with SCI who are sequentially admitted during the 42-month recruitment period
  2. * Meet the following Model Systems entry criteria with evidence of BP instability
  3. * 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.
  4. * Have trouble with your blood pressure as determined by your doctor.
  5. * 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.
  6. * You are not dependent on a ventilator at this time.
  7. * You do not have a history of implanted pacemaker/defibrillator or significant coronary artery disease.
  1. * Implanted brain/spine/nerve stimulators, cochlear implants, cardiac pacemaker/defibrillator, or intracardiac lines
  2. * Open skin lesions on or near the electrode placement sites (neck, upper back)
  3. * Significant coronary artery or cardiac conduction disease
  4. * Recent history of myocardial infarction
  5. * Insufficient mental capacity to understand and independently provide consent
  6. * Pregnancy
  7. * Cancer
  8. * Deemed unsuitable by study physician

Contacts and Locations

Study Contact

Jorge Chavez, BS
CONTACT
914-343-0713
Jorge.Chavez2@mountsinai.org

Principal Investigator

Jill Wecht, EdD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Mount Sinai Spinal Cord Injury Model System
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Jill Wecht, EdD, PRINCIPAL_INVESTIGATOR, 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 Date2022-03-18
Study Completion Date2027-02

Study Record Updates

Study Start Date2022-03-18
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Transcutaneous Spinal Cord Stimulation
  • Neuromodulation
  • Spinal Cord Stimulation
  • Blood Pressure Disorders
  • Cerebral Blood Flow Velocity
  • Acute Inpatient Rehabilitation

Additional Relevant MeSH Terms

  • Acute Spinal Cord Injury
  • Blood Pressure
  • Hypotension