Clinical trial NCT06320171: Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System
Official title: Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion:

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

Exclusion:

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

Primary outcomes:
measure: Systolic and diastolic Blood Pressure:
timeFrame: before the intervention, and 10 minutes after the intervention
measure: Heart rate
timeFrame: Before the intervention, and 10 minutes after the intervention
Secondary outcomes:
measure: Ultrasonographic variables: Cross-sectional area of the jugular vein
timeFrame: Before the intervention, and 10 minutes after the intervention
measure: Ultrasonographic variables:Cross-sectional area of the common carotid
timeFrame: Before the intervention, and 10 minutes after the intervention
measure: Ultrasonographic variables:Thickness of the common carotid
timeFrame: Before the intervention, and 10 minutes after the intervention
measure: Ultrasonographic variables:Peak systolic velocity.
timeFrame: Before the intervention, and 10 minutes after the intervention
measure: Cortisol measurement
timeFrame: Before the intervention, and 10 minutes after the intervention
Other outcomes:
Locations:
city: Villaviciosa De Odón
country: Spain
facility: Universidad Europea de Madrod
Study officials:
References: