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Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Mark S. Nash, Ph.D., FACSM, University of Miami
Sponsor:
Information provided by (Responsible Party):
Mark S. Nash, Ph.D., FACSM, University of Miami
ClinicalTrials.gov Identifier:
NCT02983266
First received: November 18, 2016
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
The purpose of this research device study is to learn more about the autonomic nervous system. This system uses nerves to send information from the brain to the rest of the body by electrical signaling and has two divisions, the sympathetic and the parasympathetic branches. It has been thought that electrical stimulation devices could be used to restore balance to the nervous system. Because most of the imbalance seems to happen due to too much sympathetic activity, the investigator plans to focus on the parasympathetic branch. Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which is the main communicator of the parasympathetic branch. The study will examine whether the investigator can decrease sympathetic activity and chronic inflammation by increasing parasympathetic activity. This is a device study that will examine the use of non-invasive vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with Spinal Cord Injury and Non-Disabled Controls.

Condition Intervention
Spinal Cord Injury Device: InTENsity MicroCombo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Study of Safety and Autonomic Responses to Non-Invasive Vagal Stimulation in Persons With Spinal Cord Injury and Non-Disabled Controls Both With and Without Inflammatory Stress

Resource links provided by NLM:


Further study details as provided by Mark S. Nash, Ph.D., FACSM, University of Miami:

Primary Outcome Measures:
  • Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability [ Time Frame: Baseline to 90 minutes post-vagal nerve stimulation ]
    Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)


Secondary Outcome Measures:
  • Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation [ Time Frame: Baseline to 90 minutes post-vagal nerve stimulation ]
    Measured by numerical heart rate in beats per minute

  • Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation [ Time Frame: Baseline to 90 minutes post-vagal nerve stimulation ]
    Measured by diastolic and systolic blood pressure (mm/Hg)

  • Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials [ Time Frame: Baseline to 90 minutes post-vagal nerve stimulation ]
    Measured by far field potentials from the brain stem

  • Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol [ Time Frame: Baseline to 90 minutes post-experimental stimulus ]
    Measured by cortisol levels in plasma

  • Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines [ Time Frame: Baseline to 90 minutes post-experimental stimulus ]
    Measured by catecholamine levels in plasma

  • Group 2 & 4: Change in acute physiological stress response by a change in heart rate [ Time Frame: Baseline to 90 minutes post-experimental stimulus ]
    Measured by numerical heart rate in beats per minute

  • Group 2 & 4: Change in acute physiological stress response by a change in blood pressure [ Time Frame: Baseline to 90 minutes post-experimental stimulus ]
    Measured by diastolic and systolic blood pressure (mm/Hg)

  • Group 3 & 4: Change in inflammatory biomarkers after vagal nerve stimulation [ Time Frame: Baseline to 90 minutes post-vagal nerve stimulation ]
    Measured by cytokine levels in plasma


Estimated Enrollment: 135
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: December 1, 2019
Estimated Primary Completion Date: December 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: Low Hertz

Participants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 1: High Hertz

Participants will receive 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Sham Comparator: Group 1: Control

Participants will receive 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 2: Pre-stressor

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session prior to receiving experimental sympathetic induction.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 2: Post-stressor

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session after experimental sympathetic induction.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Placebo Comparator: Group 2: Control

Participants will receive 10 or 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session prior to receiving experimental sympathetic induction.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 3: 30 Hz

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 4: 30 Hz

Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Participants will also receive stimulation on a subsequent session prior to urodynamic testing.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.
Experimental: Group 1: Response

Participants will receive 10-30 hertz stimulation to the left auricular branch of the vagus nerve, delivered over the course of 1 hour.

Device: InTENsity MicroCombo

Device: InTENsity MicroCombo
An electrotherapy device.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Group 1 & 2:

Inclusion Criteria:

  1. Age 18-65
  2. Willingness to participate in the study

Exclusion Criteria:

  1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
  2. Use of a hearing aid in the left ear
  3. Use of an implanted insulin or morphine (pain) pump
  4. Self-reported history of syncope from known or unknown origins
  5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)

Group 3:

Inclusion Criteria:

  1. Age 18-65
  2. Overweight, with a BMI ≥ 27
  3. Presence of chronic inflammation, with C-reactive protein values > 3 mg/l
  4. Willingness to participate in the study

Exclusion Criteria:

  1. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
  2. Use of a hearing aid in the left ear
  3. Use of an implanted insulin or morphine (pain) pump
  4. Self-reported history of syncope from known or unknown origins
  5. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
  6. Use of statin drugs

Group 4:

Inclusion Criteria:

  1. Age 18-65
  2. ≥ 1-year post-injury
  3. Bladder management by clean intermittent catheterization
  4. Spinal cord injury resulting in Paraplegia level T1 to T6 and motor-complete (AIS A or B) impairment. Injury level and impairment will be confirmed by an ASIA exam conducted less than 2 years before study entry. If longer than 2 years, we will have a certified rater repeat the exam.
  5. Participant report of symptoms related to autonomic dysreflexia during episodes of full bladder or voiding, including elevated BP, mild headache, paresthesia, chills, nasal congestion, flushing of the skin, or diaphoresis.
  6. Willingness to participate in the study.

Exclusion Criteria:

  1. Currently hospitalized
  2. American Spinal Injury Association (AIS) C-E
  3. Currently using an insulin, morphine (pain), or intrathecal pump
  4. Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
  5. Use of a hearing aid in the left ear
  6. Self-reported history of syncope from known or unknown origins
  7. Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02983266

Contacts
Contact: Crystal Noller, Ph.D. 305-243-6320 cnoller@med.miami.edu

Locations
United States, Florida
The Miami Project to Cure Paralysis/ University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Crystal Noller, Ph.D.    305-243-6320    cnoller@med.miami.edu   
Principal Investigator: Mark S Nash, Ph.D.         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Mark S Nash, Ph.D. University of Miami
  More Information

Responsible Party: Mark S. Nash, Ph.D., FACSM, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02983266     History of Changes
Other Study ID Numbers: 20150478
Study First Received: November 18, 2016
Last Updated: June 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mark S. Nash, Ph.D., FACSM, University of Miami:
Hyperadrenergia
Inflammatory stress

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on August 22, 2017