Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

NCT ID: NCT05556902

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2030-05-01

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.

Conditions

Blood Pressure; Low Back Pain; Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Permanent Epidural Spinal Cord Stimulation

Intervention Type: DEVICE

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Permanent Epidural Spinal Cord Stimulation

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Marshall Holland

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marshall Holland, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chris Gonzalez, MS

Role: CONTACT

clgonzalez@uabmc.edu

(205) 975-3732

Facility Contacts

Marshall Holland, MD

Role: primary

mtholland@uabmc.edu

205-934-2654

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UAB

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300009200

Identifier Type: -

Identifier Source: org_study_id