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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The intervention in the study involves a unique application of 20min of NESA microcurrents During the intervention, patients were seated comfortably on a sofa with their backs supported. NESA, a portable, noninvasive neuromodulation device, delivered low-frequency (1.3-14.28 Hz), low-intensity (0.1-0.9 mA), low-voltage (±3 V) microcurrents through 24 electrodes placed on the distal nerve endings of the wrists and ankles (six electrodes per limb). Direct stimulation of the autonomic nervous system was achieved using program 7 of the device with a directional electrode placed at the level of the C7 spinous process. This configuration established a circulating bioelectric circuit within the body, stimulating the autonomic nervous system below the patient's sensory threshold |
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| Placebo | Placebo Comparator | The placebo group followed the same procedure, except that no current was applied during their 20-minute session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Invasive neuromodulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic Blood Pressure: | The pressure in the arteries during the contraction of the heart muscle. Measured with sphingomanometer. | before the intervention, and 10 minutes after the intervention |
| Heart rate | Hearbears per minute | Before the intervention, and 10 minutes after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasonographic variables: Cross-sectional area of the jugular vein | 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 |
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Inclusion:
- Age between: 18-55 years, both sexes.
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Madrod | Villaviciosa de Odón | Spain |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo | Other | The placebo group followed the same procedure, except that no current was applied during their 20-minute session. |
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Cross-sectional area of the common carotid
| Before the intervention, and 10 minutes after the intervention |
| Ultrasonographic variables:Thickness of the common carotid | Thickness of the common carotid | Before the intervention, and 10 minutes after the intervention |
| Ultrasonographic variables:Peak systolic velocity. | Peak systolic velocity. | Before the intervention, and 10 minutes after the intervention |
| Cortisol measurement | Measure of cortisol level. | Before the intervention, and 10 minutes after the intervention |