Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
2 other identifiers
interventional
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2022
CompletedFirst Submitted
Initial submission to the registry
September 2, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
August 28, 2025
August 1, 2025
6.8 years
September 2, 2022
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
Treatment
EXPERIMENTALPatients that proceed with permanent implantation of a spinal cord stimulator.
Control
NO INTERVENTIONPatients who do not proceed with permanent implantation of a spinal cord stimulator.
Interventions
Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marshall Holland, MD
The University of Alabama at Birmingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 27, 2022
Study Start
August 2, 2022
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2030
Last Updated
August 28, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share