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Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects

NCT06294457 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-05

No results posted yet for this study

Summary

Objectives

Main objective:

Assess the effectiveness of non-invasive neuromodulation treatment (NESA) for the management of constipation in patients without diagnosed pathology in Spain

Secondary objectives:

Evaluate the improvement in sleep quality Analyze the improvement in blood pressure quality Measure the improvement in cortisol quality Determine if there is an improvement in heart rate

Conditions

Interventions

DEVICE

Non-Invasive Neuromodulation NESA

Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus, responsible for the innervation of the rectum. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs and the large intestine are covered through the sympathetic paravertebral ganglia and the sacral plexus.

Sponsors & Collaborators

  • Universidad Europea de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2024-03-31
Completion
2024-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294457 on ClinicalTrials.gov