RECRUITING

Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute 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

The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period. The main questions it aims to answer are: 1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared. 2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg? Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.

Official Title

Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study

Quick Facts

Study Start:2023-06
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05731986

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. * 7-30 days after injury
  2. * Injury level ≥T2 (thoracic level)
  3. * American Spinal Injury Association Impairment Scale (AIS) A-C
  4. * Exhibits at least one of the following hypotensive symptoms:
  5. 1. Baseline hypotension - resting supine or seated 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 (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
  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. * Initiated on new cardiac medications within the past 5 days
  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

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 Date2023-06
Study Completion Date2024-08

Study Record Updates

Study Start Date2023-06
Study Completion Date2024-08

Terms related to this study

Keywords Provided by Researchers

  • Transcutaneous Spinal Cord Stimulation
  • Spinal stimulation
  • Orthostatic Hypotension
  • Blood Pressure
  • Neuromodulation
  • Acute spinal cord injury
  • Hypotension
  • Acute inpatient rehabilitation

Additional Relevant MeSH Terms

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