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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

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ClinicalTrials.gov Identifier: NCT05556902
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Marshall Holland, University of Alabama at Birmingham

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Blood Pressure Low Back Pain Hypertension Device: Permanent Epidural Spinal Cord Stimulation Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Patients that proceed with permanent implantation of a spinal cord stimulator.
 Device: Permanent Epidural Spinal Cord Stimulation
Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
No Intervention: Control
Patients who do not proceed with permanent implantation of a spinal cord stimulator.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05556902


Contacts
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Contact: Chris Gonzalez, MS (205) 975-3732 clgonzalez@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Marshall Holland, MD    205-934-2654    mtholland@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Marshall Holland, MD The University of Alabama at Birmingham
More Information
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Responsible Party: Marshall Holland, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05556902    
Other Study ID Numbers: IRB-300009200
UAB ( Other Identifier: UAB )
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marshall Holland, University of Alabama at Birmingham:
Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
SCS
Arterial Blood Pressure
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations