RECRUITING

Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury

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

The study aims to explore how cardiovascular function changes in the first year after a spinal cord injury, and to see how different treatments, like spinal stimulation through the skin (transcutaneous spinal stimulation), affect blood pressure. The main questions are: How does stimulation affect blood pressure over the year? What is the level of cardiovascular activation throughout the year? The study will start during the inpatient stay at the Kessler Institute for Rehabilitation and continue after discharge as an outpatient, totaling about 20-29 sessions over the year.

Official Title

Assessing Cardiovascular Effects: Is There a Time Too Early for Spinal Stimulation in Acute SCI? A Year-Long Evaluation of Autonomic Function Following Injury

Quick Facts

Study Start:2025-04-01
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06841198

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 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with a spinal cord injury undergoing inpatient rehabilitation at the Kessler Institute for Rehabilitation
  2. * Between 18-75 years old
  3. * 7-50 days after injury
  4. * Injury level ≥ T6 (a cervical or a high-level chest injury)
  5. * Individuals experiencing low blood pressure after the injury
  6. * American Spinal Injury Association Impairment Scale (AIS) A or B
  1. * A ventilator is needed for breathing.
  2. * Devices such as brain/spine/nerve stimulators, a cardiac pacemaker/defibrillator, or intra-cardiac lines are present in the body.
  3. * There is a significant disease affecting the blood vessels or signals in the heart, or a recent heart attack (myocardial infarction) has occurred.
  4. * A new medication has been prescribed to treat blood pressure or a heart problem within the last five days (excluding midodrine).
  5. * There is a known infection in the body (e.g., urinary tract infection) or a current illness (e.g., recent diagnosis of deep vein thrombosis (DVT) or other blood clotting issues, and/or a pressure injury that might interfere with the study).
  6. * There is a history of seizures.
  7. * Pregnancy.

Contacts and Locations

Study Contact

Leighann Martinez, BA
CONTACT
(973)324-3557
lmartinez@kesslerfoundation.org

Principal Investigator

Einat Engel-Haber, MD
PRINCIPAL_INVESTIGATOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Einat Engel-Haber, MD, PRINCIPAL_INVESTIGATOR, Kessler Foundation

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 Date2025-04-01
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Transcutaneous Spinal Cord Stimulation
  • spinal cord stimulation
  • orthostatic hypotension
  • blood pressure
  • cardiovascular
  • neuromodulation
  • acute spinal cord injury
  • chronic spinal cord injury
  • inpatient rehabilitation
  • tilt testing
  • cold pressor test
  • ambulatory blood pressure monitoring
  • autonomic dysfunction following spinal cord injury

Additional Relevant MeSH Terms

  • Spinal Cord Injuries (SCI)
  • Orthostatic Hypotension, Dysautonomic
  • Cardiovascular
  • Transcutaneous Spinal Stimulation