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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
The purpose of this study in patients undergoing routine care epidural spinal cord stimulation (SCS) is to determine 1) whether SCS reduces arterial blood pressure (BP) in patients which chronic low back pain and hypertension, 2) whether higher baseline BP (i.e., hypertension) predicts reductions in pain following SCS, and finally 3) whether different SCS waveforms elicits stimulus-evoked compound action potentials (ECAPs) in spinal cord and at the cortex (electroencephalography, and magnetoenchphalography).
Conditions:
🦠 Blood Pressure 🦠 Low Back Pain 🦠 Hypertension
🗓️ Study Start (Actual) 2 August 2022
🗓️ Primary Completion (Estimated) 1 May 2029
✅ Study Completion (Estimated) 1 May 2030
👥 Enrollment (Estimated) 80
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Male or Female, age 18-89
    • 2. Chronic pain for more than 3 months
    • 3. Willing to visit a research lab
    • 4. Willing to undergo a blood draw
    • 5. Able to provide written informed consent
    • Exclusion Criteria
    • 1. History of neurological disease (e.g., dementias, Parkinson's)
    • 2. History of stroke
    • 3. Current diagnosis of cancer
    • 4. Subject is unwilling or unable to comply with the protocol
Ages Eligible for Study: 18 Years to 89 Years (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 2 September 2022
  • First Submitted that Met QC Criteria 23 September 2022
  • First Posted 27 September 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024
I'm interested ...!!