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Recruiting NCT05556902

NCT05556902 Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

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Clinical Trial Summary
NCT ID NCT05556902
Status Recruiting
Phase
Sponsor University of Alabama at Birmingham
Condition Blood Pressure
Study Type INTERVENTIONAL
Enrollment 80 participants
Start Date 2022-08-02
Primary Completion 2029-05-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 89 Years
Study Type INTERVENTIONAL
Interventions
Permanent Epidural Spinal Cord Stimulation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 80 participants in total. It began in 2022-08-02 with a primary completion date of 2029-05-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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).

Eligibility Criteria

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

Contact & Investigator

Central Contact

Chris Gonzalez, MS

✉ clgonzalez@uabmc.edu

📞 (205) 975-3732

Principal Investigator

Marshall Holland, MD

PRINCIPAL INVESTIGATOR

The University of Alabama at Birmingham

Frequently Asked Questions

Who can join the NCT05556902 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05556902 currently recruiting?

Yes, NCT05556902 is actively recruiting participants. Contact the research team at clgonzalez@uabmc.edu for enrollment information.

Where is the NCT05556902 trial being conducted?

This trial is being conducted at Birmingham, United States.

Who is sponsoring the NCT05556902 clinical trial?

NCT05556902 is sponsored by University of Alabama at Birmingham. The principal investigator is Marshall Holland, MD at The University of Alabama at Birmingham. The trial plans to enroll 80 participants.

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