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Transcutaneous Vagus Nerve Stimulation for the Treatment of Lupus

NCT02917265 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-03-03

Study results available
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Summary

This is a 3-month double blinded randomized controlled study of transcutaneous electrical vagus nerve stimulation (tVNS) compared to a sham stimulation for the treatment of patients with active systemic lupus erythematosus (SLE).

Conditions

Interventions

DEVICE

TENS for vagus stimulation

TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve.

DEVICE

TENS for sham stimulation

TENS electrodes are applied on an area of the external ear devoid of vagus innervation.

Sponsors & Collaborators

  • Oklahoma Medical Research Foundation

    collaborator OTHER

  • University of Oklahoma

    collaborator OTHER

  • Aikaterini Thanou

    lead INDIV

Principal Investigators

  • Aikaterini Thanou, MD · Oklahoma Medical Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-05-31
Completion
2018-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02917265 on ClinicalTrials.gov