Clinical trial NCT05556902: Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Official title: Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Low Back Pain
Hypertension
Keywords: Spinal Cord Stimulation
Epidural Spinal Cord Stimulation
SCS
Arterial Blood Pressure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Arterial Blood Pressure Change
timeFrame: Baseline (1 week pre-op)
measure: Arterial Blood Pressure Change
timeFrame: Visit 2 (4-6 weeks post-op)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Marshall Holland, MD
role: PRINCIPAL_INVESTIGATOR
References: