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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320171
• Other study ID #: 240118,2024-481
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion:

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

Exclusion:

• Cardiovascular disease.

• Specific pharmacology.

• Hypertension.

• Diabetes.

• Systemic diseases.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Heart rate	Hearbears per minute	During the neuromodulation.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Ultrasonographic variables:Peak systolic velocity.	Peak systolic velocity.	Before and after the intervention 15, 30 or 45 minutes, depending on the intervention arm.
Secondary	Cortisol measurement	Measure of cortisol level.	Before and after the intervention 15, 30 or 45 minutes, depending on the intervention arm.