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Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

NCT02983266 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-10-09

No results posted yet for this study

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

Interventions

DEVICE

InTENsity MicroCombo

An electrotherapy device.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Mark S Nash, Ph.D. · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02983266 on ClinicalTrials.gov