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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Primary Purpose

Blood Pressure, Low Back Pain, Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Permanent Epidural Spinal Cord Stimulation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, SCS, Arterial Blood Pressure

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female, age 30-89
  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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Patients that proceed with permanent implantation of a spinal cord stimulator.

Patients who do not proceed with permanent implantation of a spinal cord stimulator.

Outcomes

Primary Outcome Measures

Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2022
Last Updated
October 2, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05556902
Brief Title
Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Official Title
Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Low Back Pain, Hypertension
Keywords
Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, SCS, Arterial Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients that proceed with permanent implantation of a spinal cord stimulator.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients who do not proceed with permanent implantation of a spinal cord stimulator.
Intervention Type
Device
Intervention Name(s)
Permanent Epidural Spinal Cord Stimulation
Intervention Description
Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
Primary Outcome Measure Information:
Title
Arterial Blood Pressure Change
Description
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Time Frame
Baseline (1 week pre-op)
Title
Arterial Blood Pressure Change
Description
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Time Frame
Visit 2 (4-6 weeks post-op)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Gonzalez, MS
Phone
(205) 975-3732
Email
clgonzalez@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall Holland, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshall Holland, MD
Phone
205-934-2654
Email
mtholland@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

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