Recruiting NCT05556902

Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

No phase Interventional Blood Pressure Low Back Pain Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Permanent Epidural Spinal Cord Stimulation.
Who it may be relevant to: Registry conditions: Blood Pressure, Low Back Pain, Hypertension. Basic parameters: 18 years — 89 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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 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.

Interventions

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

Primary outcome measures

Arterial Blood Pressure Change [Time frame: Baseline (1 week pre-op)]
Arterial Blood Pressure Change [Time frame: Visit 2 (4-6 weeks post-op)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 1 center

University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT05556902 · IRB-300009200 · UAB

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗