Recruiting

Epidural Stimulation

Sponsor:

University of Alabama at Birmingham

Code:

NCT05556902

Conditions

Blood Pressure

Low Back Pain

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Permanent Epidural Spinal Cord Stimulation

Study Details

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).

Conditions

Blood Pressure

Low Back Pain

Hypertension

Study ID

NCT05556902

Start date

Aug 2, 2022

Status verified date

Aug, 2026

Completion date

May 1, 2030

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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

no intervention: Control

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

Interventions

Permanent Epidural Spinal Cord Stimulation

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Chris Gonzalez, MS

(205) 975-3732clgonzalez@uabmc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Marshall Holland, MD

2059342654mtholland@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Spinal Cord Stimulation
  • Epidural Spinal Cord Stimulation
  • SCS
  • Arterial Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-11.