Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Conditions
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Blood Pressure, Low Back Pain, Hypertension

Intervention / Treatment
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* Device: Permanent Epidural Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients that proceed with permanent implantation of a spinal cord stimulator. | Device: Permanent Epidural Spinal Cord Stimulation<br>* Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.<br>|
| No Intervention: Control<br>Patients who do not proceed with permanent implantation of a spinal cord stimulator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Blood Pressure Change | The research team will assess systolic and diastolic blood pressure with an arm cuff. | Baseline (1 week pre-op) | 
| Arterial Blood Pressure Change | The research team will assess systolic and diastolic blood pressure with an arm cuff. | Visit 2 (4-6 weeks post-op) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCS, Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, Arterial Blood Pressure