Blood PressureNCT05556902
Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
A study testing Permanent Epidural Spinal Cord Stimulation in people with Blood Pressure and Low Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Blood Pressure, Low Back Pain, Hypertension
- What is being tested?
- Permanent Epidural Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2022to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Marshall Holland, MD, 2059342654, mtholland@uabmc.edu
About this study
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).
Read the 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.
- Conditions
- Blood Pressure, Low Back Pain, Hypertension
- Being tested
- Permanent Epidural Spinal Cord Stimulation
- Keywords
- Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, SCS, Arterial Blood Pressure
- Medical subject headings
- Low Back Pain, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permanent Epidural Spinal Cord StimulationDevice
Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients that proceed with permanent implantation of a spinal cord stimulator. Receives: Device: Permanent Epidural Spinal Cord Stimulation |
| Control | No intervention | Patients who do not proceed with permanent implantation of a spinal cord stimulator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Measured: Baseline (1 week pre-op)
Arterial Blood Pressure Change
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Measured: Visit 2 (4-6 weeks post-op)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start2 Aug 2022
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marshall Holland, University of Alabama at Birmingham
- Investigators
- Marshall Holland, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556902
- Sponsor's protocol ID
- IRB-300009200
- Other IDs
- UAB
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT05556902
- Acronym / sponsor ID
- IRB-300009200
- Conditions
- Blood Pressure, Low Back Pain, Hypertension
- Keywords
- Spinal Cord Stimulation, Epidural Spinal Cord Stimulation, SCS, Arterial Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Permanent Epidural Spinal Cord StimulationPatients that proceed with permanent implantation of a spinal cord stimulator. |
| Control | No intervention | –Patients who do not proceed with permanent implantation of a spinal cord stimulator. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permanent Epidural Spinal Cord StimulationPermanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain. | Device | Treatment |
Primary outcome
Arterial Blood Pressure Change
Time frame: Baseline (1 week pre-op)
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Arterial Blood Pressure Change
Time frame: Visit 2 (4-6 weeks post-op)
The research team will assess systolic and diastolic blood pressure with an arm cuff.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marshall Holland, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permanent Epidural Spinal Cord Stimulation in people with Blood Pressure and Low Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chris Gonzalez, MS ((205) 975-3732, clgonzalez@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Blood Pressure Change (time frame: Baseline (1 week pre-op)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.