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

NCT06320171 | Completed DMC

• 1 other identifier: 240118,2024-481
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Ultrasonographic variables: 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

  Before the intervention, and 10 minutes after the intervention

• Ultrasonographic variables:Thickness of the common carotid

  Before the intervention, and 10 minutes after the intervention

• Ultrasonographic variables:Peak systolic velocity.

  Before the intervention, and 10 minutes after the intervention

• Cortisol measurement

  Before the intervention, and 10 minutes after the intervention

Study Arms (2)

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

Placebo

PLACEBO COMPARATOR

The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

Other: Placebo

Interventions

Non-Invasive neuromodulation DEVICE

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.

Experimental

Placebo OTHER

The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 20, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)