Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT06320171
• Lead Sponsor: Universidad Europea de Madrid

Brief Summary

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). The investigators hypothesized that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.

Detailed Description

The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). We hypothesize that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.A total sample of forty participants (N = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. Prior to entering the study, all participants received information about the study and signed a consent form to participate. The study subjects were divided into two equally distributed groups (A: NESA = 20; B: Placebo = 20) and were blinded to the study group allocation. Participants in the placebo group underwent the same procedural phases as those in the intervention group. However, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-20
• Study Start: 2024-04-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic and diastolic Blood Pressure:	before the intervention, and 10 minutes after the intervention	The pressure in the arteries during the contraction of the heart muscle. Measured with sphingomanometer.
Heart rate	Before the intervention, and 10 minutes after the intervention	Hearbears per minute

Secondary Outcome Measures

Name	Time	Method
Ultrasonographic variables: Cross-sectional area of the jugular vein	Before the intervention, and 10 minutes after the intervention	Cross-sectional area of the jugular vein
Ultrasonographic variables:Cross-sectional area of the common carotid	Before the intervention, and 10 minutes after the intervention	Cross-sectional area of the common carotid
Ultrasonographic variables:Thickness of the common carotid	Before the intervention, and 10 minutes after the intervention	Thickness of the common carotid
Ultrasonographic variables:Peak systolic velocity.	Before the intervention, and 10 minutes after the intervention	Peak systolic velocity.
Cortisol measurement	Before the intervention, and 10 minutes after the intervention	Measure of cortisol level.

Trial Locations

Locations (1)

Universidad Europea de Madrod; 🇪🇸 Villaviciosa De Odón, Spain