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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Non-Invasive neuromodulation; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Villaviciosa De Odón, Spain
    • Universidad Europea de Madrod

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion:

- Age between: 18-55 years, both sexes.

Exclusion:

• Cardiovascular disease.
• Specific pharmacology.
• Hypertension.
• Diabetes.
• Systemic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The intervention in the study involves a unique application of 20min of NESA microcurrents During the intervention, patients were seated comfortably on a sofa with their backs supported. NESA, a portable, noninvasive neuromodulation device, delivered low-frequency (1.3-14.28 Hz), low-intensity (0.1-0.9 mA), low-voltage (±3 V) microcurrents through 24 electrodes placed on the distal nerve endings of the wrists and ankles (six electrodes per limb). Direct stimulation of the autonomic nervous system was achieved using program 7 of the device with a directional electrode placed at the level of the C7 spinous process. This configuration established a circulating bioelectric circuit within the body, stimulating the autonomic nervous system below the patient's sensory threshold	Device: Non-Invasive neuromodulation; Direct stimulation of the autonomic nervous system was achieved using Program 7 (P7) of the device, with a directional electrode positioned at the level of the C7 spinous process. P7 delivered a biphasic polarity current with oscillatory frequencies ranging from 1.92 to 14.29 Hz and variable intensities between 0.1 and 0.9 mA.
Placebo Comparator: Placebo; The placebo group followed the same procedure, except that no current was applied during their 20-minute session.	Other: Placebo; The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 240118,2024-481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No