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Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use

NCT02673684 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-05-27

Study results available
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Summary

The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.

Conditions

  • Pain (Visceral, Somatic, or Neuropathic)

Interventions

DEVICE

Experimental NSS

5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.

DEVICE

Sham NSS

(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.

Sponsors & Collaborators

  • Innovative Health Solutions

    collaborator INDUSTRY

  • Defense and Veterans Center for Integrative Pain Management

    lead OTHER

Principal Investigators

  • Chester Buckenmaier, MD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-05-01
Completion
2016-05-01
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 NCT02673684 on ClinicalTrials.gov