Transcutaneous Stimulation in Spinal Cord Injury
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Conditions:
🦠 Spinal Cord Injury
🗓️ Study Start (Actual) 1 April 2022
🗓️ Primary Completion (Estimated) 31 July 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * above the age of 18 years old
    • * individuals with traumatic spinal cord injuries at or above T6
    • * duration of injury if more than 1 year
    • * non-ambulatory
    • * American spinal injury association scale A, B or C
    • * able to provide consent
    • * non-ventilator
    • * hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)

    Exclusion Criteria:

    • * acute illness or infection
    • * documented history of controlled or uncontrolled diabetes
    • * any other neurological disease other than spinal cord injury
    • * cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
    • * present of history of thrombosis in the last 12 months, severe contractures
    • * pregnant
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 November 2021
  • First Submitted that Met QC Criteria 30 December 2021
  • First Posted 6 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 April 2024
  • Last Update Posted 22 April 2024
  • Last Verified April 2024