NCT05704153

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Systemic Lupus Erythematosus
• Autoimmune Disorder
• Vagus Nerve Autonomic Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-09-30
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-01-30
• Last updated: 2024-02-28

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study