Efectivity of Non-invasive Neuromodulation in Parasympathic Nervous System and Vascular System
- Conditions
- Hypertension
- Interventions
- Device: Non-Invasive neuromodulation
- Registration Number
- NCT06320171
- Lead Sponsor
- Universidad Europea de Madrid
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 min Non-Invasive neuromodulation The intervention in the study involves a unique application of 30 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. These impulses elicit responses from the autonomic nervous system (ANS), with the goal of measuring changes in various vascular and ultrasonographic variables proposed by the research team of the Universidad Europea de Madrid. 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. 45 min Non-Invasive neuromodulation The intervention in the study involves a unique application of 45 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses. 15 min Non-Invasive neuromodulation The intervention in the study involves a unique application of 15 min of NESA microcurrents The applied program, designated as Program 7, is aimed exclusively at affecting the autonomic nervous system of the patient. Therefore, no start-up or current preparation programs are applied for this particular intervention. This program involves changes in stimulus times and frequencies, varying from 192 Hz to 1429 Hz, generating symmetrical positive and negative polarity impulses.
- Primary Outcome Measures
Name Time Method Systolic and diastolic Blood Pressure: 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 Before the intervention, and 10 minutes after the intervention Hearbears per minute
- Secondary Outcome Measures
Name Time Method Ultrasonographic variables: Cross-sectional area of the jugular vein Before the intervention, and 10 minutes after the intervention Cross-sectional area of the jugular vein
Ultrasonographic variables:Cross-sectional area of the common carotid Before the intervention, and 10 minutes after the intervention Cross-sectional area of the common carotid
Ultrasonographic variables:Thickness of the common carotid Before the intervention, and 10 minutes after the intervention Thickness of the common carotid
Ultrasonographic variables:Peak systolic velocity. Before the intervention, and 10 minutes after the intervention Peak systolic velocity.
Cortisol measurement Before the intervention, and 10 minutes after the intervention Measure of cortisol level.
Trial Locations
- Locations (1)
Universidad Europea de Madrod
🇪🇸Villaviciosa De Odón, Spain