RECRUITING

The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (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 investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position). The main questions it aims to answer are: 1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)? 2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability? Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.

Official Title

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury

Quick Facts

Study Start:2023-05-01
Study Completion:2024-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05725499

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. * Spinal cord injury for greater than or equal to 6 months
  2. * Injury level ≥ T6 (thoracic level)
  3. * American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
  4. * Exhibits at least one of the following hypotensive symptoms:
  5. 1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \< 90mmHg;
  6. 2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
  7. 3. Symptoms of orthostasis with a drop of SBP (\<90mmHg) from supine to sitting
  1. * Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
  2. * Ventilator-dependent
  3. * History of implanted brain/spine/nerve stimulators
  4. * Cardiac pacemaker/defibrillator or intra-cardiac lines
  5. * Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
  6. * Insufficient mental capacity to understand and independently provide consent
  7. * Pregnancy
  8. * Cancer
  9. * Deemed unsuitable by study physician

Contacts and Locations

Study Contact

LeighAnn Martinez, BA
CONTACT
(973)324-3557
lmartinez@kesslerfoundation.org
Einat Engel-Haber, MD
CONTACT
ehaber@kesslerfoundation.org

Principal Investigator

Gail F Forrest, Phd
PRINCIPAL_INVESTIGATOR
Kessler Foundation

Study Locations (Sites)

Kessler Foundation
West Orange, New Jersey, 07052
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

  • Gail F Forrest, Phd, 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 Date2023-05-01
Study Completion Date2024-03

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2024-03

Terms related to this study

Keywords Provided by Researchers

  • Transcutaneous Spinal Cord Stimulation
  • Spinal Stimulation
  • Orthostatic Hypotension
  • Blood Pressure
  • Neuromodulation

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Hypotension
  • Orthostatic Hypotension
  • Spinal Cord Diseases
  • Cardiovascular Diseases
  • Trauma, Nervous System
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Blood Pressure