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NCT Number: NCT05556902

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).

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Marshall Holland, MD

CONTACT

[email protected]

205-934-2654

About this study

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).

The Investigators will identify patients with chronic pain who are scheduled for SCS implant at the University of Alabama at Birmingham for management of chronic neuropathic pain as part of routine care. The research team will assess BP with an arm cuff arm cuff before and after the implant among patients providing written informed consent.

The Investigators' central clinical hypothesis is that SCS decreases blood pressure in patients with chronic pain and comorbid hypertension. The Investigators further hypothesize that the SCS will improve serological markers of sympathetic nerve activity and kidney function, possibly due to reductions in spinal cord sympathetic nerve activity. A secondary hypothesis is that higher baseline blood pressure predicts larger reductions in blood pressure following SCS implant.

Additionally, this project seeks to expand knowledge on therapeutic mechanisms of SCS via recording electrophysiological responses at the spinal cord (via adjacent, unused SCS contacts) and from EEG scalp recordings over the cerebral cortex.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or Female, age 18-89
  • Chronic pain for more than 3 months
  • Willing to visit a research lab
  • Willing to undergo a blood draw
  • Able to provide written informed consent

Exclusion criteria

  • History of neurological disease (e.g., dementias, Parkinson's)
  • History of stroke
  • Current diagnosis of cancer
  • Subject is unwilling or unable to comply with the protocol

Treatment and study plan

Permanent Epidural Spinal Cord Stimulation

Device

Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.

Primary outcomes

  1. Arterial Blood Pressure Change

    Time frame: Baseline (1 week pre-op)

    The research team will assess systolic and diastolic blood pressure with an arm cuff.

  2. Arterial Blood Pressure Change

    Time frame: Visit 2 (4-6 weeks post-op)

    The research team will assess systolic and diastolic blood pressure with an arm cuff.

Study contacts

Contact information is provided by the study sponsor or research team.

Chris Gonzalez, MS

CONTACT

[email protected]

(205) 975-3732

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Sep 27, 2022
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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