Clinical trial NCT06294457: Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
Official title: Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for the Management of Constipation Without Diagnosed Pathology in Students of the European University of Madrid (Spain)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Detailed description: Background and Current State of the Topic Non-invasive NESA neuromodulation is based on a superficial treatment through electrical microcurrents, regulated by Wilder's law and hormesis.

It involves applying a low-frequency biphasic current that emits up to 19,000 pulses/minute, with an intensity varying from 0.1 to 1 milliwatt and a frequency from 1 to 15 hertz, generating a weak and physiological electrical signal which is amplified due to its entry through many pathways via electrodes placed on the limbs .

Imperceptible sensations are produced in areas of low impedance for individuals. All these parameters fluctuate according to the device's programs. NESA aims to neuromodulate the Autonomic Nervous System (ANS), inducing changes in the endogenous responses of dysfunctional systems or those with pathologies. The ANS is an essential component of the Nervous System responsible for maintaining the organism's homeostasis and responding to internal or external changes through adaptation responses. It consists of the sympathetic and parasympathetic systems, involuntary systems in charge of regulating respiration, circulation, metabolism, digestion, body temperature, reproduction, and glandular secretion.

Constipation is defined as a gastrointestinal motility disorder characterized by difficult or infrequent bowel movements (fewer than three times per week). It is one of the most common gastrointestinal diseases, affecting between 0.7% and 29.6% of the population in developed and developing countries. Constipation can affect overall quality of life. It may trigger sleep disorders, anxiety, depression, and other psychological complications, even increasing mortality associated with conditions such as hypertension, cardiovascular diseases, cerebrovascular diseases, and the incidence of colon cancer.

Since the etiology and mechanism of constipation are complicated, many of the currently available treatments are not effective for many people.

Given that NESA performs a non-invasive neuromodulation on the ANS through the nerve pathways involved in improving constipation, effects in this regard are expected.

Non-invasive NESA neuromodulation has emerged as a promising area of research with potentially significant results in terms of improving sleep quality and daytime sleepiness, nerve and cognitive function, quality of life, and pain. This study aims to clarify these aspects, establishing a solid foundation for clinical practice and future research.

Justification The ANS is responsible for maintaining the organism's homeostasis and responding to internal or external changes through adaptation responses. The gastrointestinal motility disorder of constipation and the irregular contractions of overactive bladder are conditions in which there are alterations in the ANS, which is why neuromodulation of the ANS can induce changes in the endogenous responses in dysfunctional systems . The chosen population is healthy or not previously diagnosed to assess them for changes in gastrointestinal motility

Eligibility criteria: Inclusion Criteria:

* Participants from 18 to 65 years old
* Sign informed consent

Exclusion Criteria:

* Diagnosed diseases at the time of the study.
* Severe previous psychiatric conditions.
* Medical contraindications that prevent the use of non-invasive neuromodulation therapy.
* Having exercised in the hours prior to the NESA treatment.
* Having consumed coffee or tobacco in the hours prior to the treatment.
* Minors.
* Individuals who have previously received any type of neuromodulation treatment.
* Cancer.

Primary outcomes:
measure: Quality of life by constipation (CVE-20)
timeFrame: 10 minutes
Secondary outcomes:
measure: Sleep Quality
timeFrame: 10 minutes
measure: Cardiac Frecuency
timeFrame: 5 minutes
measure: Arterial pressure
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
References: