Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-29 @ 11:44 PM
Study NCT ID:
NCT06294457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
Sponsor:
Universidad Europea de Madrid
Organization:
Study Overview
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)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: