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Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)

NCT05704153 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-28

No results posted yet for this study

Summary

The overall goal of this clinical trial is to evaluate the causality relationship between the non vagus nerve stimulation waveform parameters and the therapeutic effect. Thus, unlocking a pathway to optimize parameters that maximize the benefits of therapy and minimize unwanted side effects. The experimental design includes the analysis of physiological signals, clinical biomarkers of disease, and clinical outcomes to determine the most effective measures for the monitoring, optimization, and personalization of non vagus nerve stimulation in systemic lupus erythematosus disease.

Conditions

Interventions

DEVICE

Parasym 1Hz

Transcutaneous auricular vagus nerve stimulation of 1Hz

DEVICE

Parasym 30Hz

Transcutaneous Auricular Vagus Nerve Stimulation of 30Hz

DEVICE

Sham Intervention

Sham stimulation

Sponsors & Collaborators

  • Universitat de Girona

    collaborator OTHER

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Imperial College London

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT05704153 on ClinicalTrials.gov