Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
VaNeSA
VaNeSA
Sponsor study identifier
interventional
18
1 country
1
Study Start
September 30, 2022
Actual (reported)Primary Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2022
Actual (reported)October 4, 2022
Actual (reported)January 30, 2023
Actual (reported)October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of patients with Systemic Lupus Erythematosus with clinical and analytic change after non-invasive vagus nerve stimulation (nVNS) at different waveform parameters
We will develop an nVNS platform with an integrated nVNS decision support system, including nVNS and physiological wearable sensors, that will optimize nVNS waveform parameters to maximize the therapeutic effect while minimizing unwanted side effects. Therapeutic effect and side effects will be measured by clinical, neurophysiological and analytic tests as described in "secondary outcome measures".
Visit 1(baseline, exploratory study, up to 30days prior to first nVNS)
Blood count
Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Erythrocyte sedimentation rate
Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C-reactive protein
Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Anti-dsDNA
Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
C3, C4
Baseline, after five days of stimulation and 1 month after stimulation. Additionally, 2 and 3months after stimulation if the biomarkers and scales of activity do not return to baseline levels
Control group to be subjected to sham stimulation.
Group of patients treated via 30Hz transcutaneous electrical nerve stimulation
Group of patients treated via 1Hz transcutaneous electrical nerve stimulation
Transcutaneous auricular vagus nerve stimulation of 1Hz
Transcutaneous Auricular Vagus Nerve Stimulation of 30Hz
Hospital Clinic
Barcelona, 08036, Spain
Contreras I, Navarro-Otano J, Rodriguez-Pinto I, Guemes A, Alves E, Rios-Garces R, Espinosa G, Alejaldre A, Beneyto A, Ramkissoon CM, Vehi J, Cervera R. Optimizing Noninvasive Vagus Nerve Stimulation for Systemic Lupus Erythematosus: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2023 Oct 13;12:e48387. doi: 10.2196/48387.
First Submitted
October 4, 2022
First Posted
January 30, 2023
Study Start
September 30, 2022
Actual (reported)Primary Completion
Laser Puncture and Program of Lifestyle Modification in Lupus Females
Sham stimulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 28, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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