Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05556902
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Aug 2, 2022
Status verified
Aug 2025
Primary completion
May 1, 2029
Completion
May 1, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Arterial Blood Pressure Change [ Time Frame: Baseline (1 week pre-op) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Marshall Holland, MD
[email protected]
205-934-2654

Find similar trials in Birmingham, AL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
University of Alabama at Birmingham· Birmingham, AL

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