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

European University

Status: Completed

Conditions: Hypertension

Treatments: Device: Non-Invasive neuromodulation; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06320171

240118,2024-481

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Exclusion:

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Device: Non-Invasive neuromodulation

Placebo

Placebo Comparator group

Description:

The placebo group followed the same procedure, except that no current was applied during their 20-minute session.

Treatment:

Other: Placebo