Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Hypertension Clinical Trial

Official title:

Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556902
• Other study ID #: IRB-300009200
• Secondary ID: UAB
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: May 1, 2030

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Chris Gonzalez, MS
• Phone: (205) 975-3732
• Email: clgonzalez[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Blood Pressure Change	The research team will assess systolic and diastolic blood pressure with an arm cuff.	Baseline (1 week pre-op)
Primary	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)