Hypertension
Conditions
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.
Interventions
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.
OTHERPlacebo
The placebo group followed the same procedure, except that no current was applied during their 20-minute session.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: \- Age between: 18-55 years, both sexes. Exclusion: * Cardiovascular disease. * Specific pharmacology. * Hypertension. * Diabetes. * Systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ultrasonographic variables:Thickness of the common carotid | Before the intervention, and 10 minutes after the intervention | Thickness of the common carotid |
| 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 |
| Cortisol measurement | Before the intervention, and 10 minutes after the intervention | Measure of cortisol level. |
| Ultrasonographic variables:Peak systolic velocity. | Before the intervention, and 10 minutes after the intervention | Peak systolic velocity. |
| 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 |
Countries
Spain
Outcome results
None listed