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

The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Device: Non-Invasive neuromodulation

Detailed Description

The study, conducted by the Universidad Europea de Madrid, examines the immediate effects of a single session using NESA microcurrents on various circulatory system variables in healthy subjects. It divides participants into three groups based on session duration (15, 30, 45 minutes), measuring pre and post-intervention changes. The focus is on autonomic nervous system responses, aiming to understand the minimum treatment characteristics needed for significant autonomic changes. Variables studied include systolic and diastolic blood pressure, heart rate, and several ultrasound measurements of the common carotid artery (CSA), including thickness and peak systolic flow velocity.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

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: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15 min; The intervention in the study involves a unique application of 15 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses.	Device: Non-Invasive neuromodulation; This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. The intensity for all sessions is set to low, following the Arndt-Schulz law. A maximum total time of 10 minutes is considered for connecting the patient to the device at the beginning and for removing the device at the end of the session.
Experimental: 30 min; The intervention in the study involves a unique application of 30 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. These impulses elicit responses from the autonomic nervous system (ANS), with the goal of measuring changes in various vascular and ultrasonographic variables proposed by the research team of the Universidad Europea de Madrid. The intensity for all sessions is set to low, following the Arndt-Schulz law. A maximum total time of 10 minutes is considered for connecting the patient to the device at the beginning and for removing the device at the end of the session.	Device: Non-Invasive neuromodulation; This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. The intensity for all sessions is set to low, following the Arndt-Schulz law. A maximum total time of 10 minutes is considered for connecting the patient to the device at the beginning and for removing the device at the end of the session.
Experimental: 45 min; The intervention in the study involves a unique application of 45 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses.	Device: Non-Invasive neuromodulation; This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. The intensity for all sessions is set to low, following the Arndt-Schulz law. A maximum total time of 10 minutes is considered for connecting the patient to the device at the beginning and for removing the device at the end of the 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 and after the intervention, 15, 30 or 45 minutes, depending on the intervention arm.
Heart rate	Hearbears per minute	During the neuromodulation.

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 and After the intervention 15, 30 or 45 minutes, depending on the intervention arm.
Ultrasonographic variables:Cross-sectional area of the common carotid	Cross-sectional area of the common carotid	Before and After the intervention 15, 30 or 45 minutes, depending on the intervention arm.
Ultrasonographic variables:Thickness of the common carotid	Thickness of the common carotid	Before and after the intervention 15, 30 or 45 minutes, depending on the intervention arm.
Ultrasonographic variables:Peak systolic velocity.	Peak systolic velocity.	Before and after the intervention 15, 30 or 45 minutes, depending on the intervention arm.
Cortisol measurement	Measure of cortisol level.	Before and after the intervention 15, 30 or 45 minutes, depending on the intervention arm.

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 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 20, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular 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