Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

NCT02983266 | Withdrawn FDA Device

• 1 other identifier: 20150478
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

Hyperadrenergia; Inflammatory stress

Outcome Measures

Primary Outcomes (1)

• Change in parasympathetic activity after vagal nerve stimulation by Heart Rate Variability

  Measured by the normal-to-normal QRS complexes of the PQRST waveform of the electrocardiogram (ECG)

  Baseline to 90 minutes post-vagal nerve stimulation

Secondary Outcomes (8)

• Group 1 & 4: Change in acute heart rate response to vagal nerve stimulation

  Baseline to 90 minutes post-vagal nerve stimulation

• Group 1 & 4: Change in acute blood pressure response to vagal nerve stimulation

  Baseline to 90 minutes post-vagal nerve stimulation

• Group 1: Change in parasympathetic activity after vagal nerve stimulation by Vagus Somatosensory Evoked Potentials

  Baseline to 90 minutes post-vagal nerve stimulation

• Group 2 & 4: Change in acute physiological stress response by a change in peripheral cortisol

  Baseline to 90 minutes post-experimental stimulus

• Group 2 & 4: Change in acute physiological stress response by a change in peripheral catecholamines

  Baseline to 90 minutes post-experimental stimulus

Study Arms (9)

Group 1: Low Hertz

EXPERIMENTAL

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

Group 1: High Hertz

EXPERIMENTAL

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

Group 1: Control

SHAM COMPARATOR

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

Group 2: Pre-stressor

EXPERIMENTAL

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

Group 2: Post-stressor

EXPERIMENTAL

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

Group 2: Control

PLACEBO COMPARATOR

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

Group 3: 30 Hz

EXPERIMENTAL

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

Group 4: 30 Hz

EXPERIMENTAL

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

Group 1: Response

EXPERIMENTAL

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

Interventions

InTENsity MicroCombo DEVICE

An electrotherapy device.

Group 1: Control; Group 1: High Hertz; Group 1: Low Hertz; Group 1: Response; Group 2: Control; Group 2: Post-stressor; Group 2: Pre-stressor; Group 3: 30 Hz; Group 4: 30 Hz

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Willingness to participate in the study

You may not qualify if:

• Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
• Use of a hearing aid in the left ear
• Use of an implanted insulin or morphine (pain) pump
• Self-reported history of syncope from known or unknown origins
• Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)
• Group 3:
• Age 18-65
• Overweight, with a BMI ≥ 27
• Presence of chronic inflammation, with C-reactive protein values \> 3 mg/l
• Willingness to participate in the study
• Use of an active electrical implant, such as a cardiac pacemaker or cochlear implant
• Use of a hearing aid in the left ear
• Use of an implanted insulin or morphine (pain) pump
• Self-reported history of syncope from known or unknown origins
• Self-reported history of cardiovascular disease or dysfunction (e.g., cardiovascular disease, arrhythmia, congestive heart failure, or stroke)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

The Miami Project to Cure Paralysis/ University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mark S Nash, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)