NCT06320171

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universidad Europea de Madrid · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Non-Invasive neuromodulation	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.
OTHER	Placebo	The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-06-01
• Completion: 2024-06-30
• First posted: 2024-03-20
• Last updated: 2025-01-07

Locations

1 site across 1 country: Spain