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Therapeutic Mechanisms of Epidural Spinal Cord Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05556902
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Marshall Holland, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE September 2, 2022
First Posted Date  ICMJE September 27, 2022
Last Update Posted Date May 7, 2024
Actual Study Start Date  ICMJE August 2, 2022
Estimated Primary Completion Date May 1, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2023)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2022)
  • 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 3 (7-10 days post-op) ]
    The research team will assess systolic and diastolic blood pressure with an arm cuff.
  • Arterial Blood Pressure Change [ Time Frame: Visit 4 (3-4 weeks post-op) ]
    The research team will assess systolic and diastolic blood pressure with an arm cuff.
  • Arterial Blood Pressure Change [ Time Frame: Visit 5 (7-8 weeks post-op) ]
    The research team will assess systolic and diastolic blood pressure with an arm cuff.
  • Laboratory Markers - Catecholamines [ Time Frame: Baseline (1 week pre-op) ]
    Blood will be collected for analysis of Catecholamines: dopamine, norepinephrine, and epinephrine and Catechol-O-methyltransferase.
  • Laboratory Markers - Catecholamines [ Time Frame: Visit 3 (7-10 days post-op) ]
    Blood will be collected for analysis of Catecholamines: dopamine, norepinephrine, and epinephrine and Catechol-O-methyltransferase.
  • Laboratory Markers - Catecholamines [ Time Frame: Visit 4 (3-4 weeks post-op) ]
    Blood will be collected for analysis of Catecholamines: dopamine, norepinephrine, and epinephrine and Catechol-O-methyltransferase.
  • Laboratory Markers - Catecholamines [ Time Frame: Visit 5 (7-8 weeks post-op) ]
    Blood will be collected for analysis of Catecholamines: dopamine, norepinephrine, and epinephrine and Catechol-O-methyltransferase.
  • Laboratory Markers - COMT [ Time Frame: Baseline (1 week pre-op) ]
    Blood will be collected for Catechol-O-methyltransferase (COMT) analysis.
  • Laboratory Markers - COMT [ Time Frame: Visit 3 (7-10 days post-op) ]
    Blood will be collected for Catechol-O-methyltransferase (COMT) analysis.
  • Laboratory Markers - COMT [ Time Frame: Visit 4 (3-4 weeks post-op) ]
    Blood will be collected for Catechol-O-methyltransferase (COMT) analysis.
  • Laboratory Markers - COMT [ Time Frame: Visit 5 (7-8 weeks post-op) ]
    Blood will be collected for Catechol-O-methyltransferase (COMT) analysis.
  • Stimulus-Evoked Compound Action Potentials (ECAPS) - Spinal Cord [ Time Frame: Visit 2 (intra-op) ]
    During stimulation sessions, unused SCS channels and EEG will be used to record local and distant stimulus-evoked activity. Participants will undergo a series of single pulses of stimulation to investigate the pattern of local neural recruitment at amplitudes inside and outside of the therapeutic window at tonic stimulation frequencies.
  • Stimulus-Evoked Compound Action Potentials (ECAPS) - Cortex [ Time Frame: Visit 2 (intra-op) ]
    During stimulation sessions EEG will be used to record distant stimulus-evoked activity. Participants will undergo a series of single pulses of stimulation to investigate the pattern of local and distant neural recruitment at standard clinical tonic and high frequencies.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
Official Title  ICMJE Therapeutic Mechanisms of Epidural Spinal Cord Stimulation
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Pressure
  • Low Back Pain
  • Hypertension
Intervention  ICMJE Device: Permanent Epidural Spinal Cord Stimulation
Permanent Spinal Cord Stimulation implanted in participants undergoing routine care for management of chronic neuropathic pain.
Study Arms  ICMJE
  • Experimental: Treatment
    Patients that proceed with permanent implantation of a spinal cord stimulator.
    Intervention: Device: Permanent Epidural Spinal Cord Stimulation
  • No Intervention: Control
    Patients who do not proceed with permanent implantation of a spinal cord stimulator.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2022)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2030
Estimated Primary Completion Date May 1, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chris Gonzalez, MS (205) 975-3732 clgonzalez@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05556902
Other Study ID Numbers  ICMJE IRB-300009200
UAB ( Other Identifier: UAB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Marshall Holland, University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marshall Holland, MD The University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP