Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06294457 |
| Other study ID # |
CI-2024-480 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2024 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Universidad Europea de Madrid |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
