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Clinical Trials/NCT06320171
NCT06320171
Completed
N/A

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

Universidad Europea de Madrid1 site in 1 country40 target enrollmentApril 1, 2024
ConditionsHypertension

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hypertension
Sponsor
Universidad Europea de Madrid
Enrollment
40
Locations
1
Primary Endpoint
Systolic and diastolic Blood Pressure:
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Europea de Madrid
Responsible Party
Principal Investigator
Principal Investigator

Vanesa Abuín

Associated Professor

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Systolic and diastolic Blood Pressure:

Time Frame: 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

Time Frame: Before the intervention, and 10 minutes after the intervention

Hearbears per minute

Secondary Outcomes

  • 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 Sites (1)

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