Effectiveness of Non-invasive Neuromodulation for Intestinal Transit in Healthy Subjects
- Conditions
- Constipation
- Interventions
- Device: Non-Invasive Neuromodulation NESA
- Registration Number
- NCT06294457
- Lead Sponsor
- Universidad Europea de Madrid
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Participants from 18 to 65 years old
- Sign informed consent
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Non-Invasive Neuromodulation NESA Non-active Non-Invasive Neuromodulation NESA Intervention Non-Invasive Neuromodulation NESA The total number of sessions to be conducted for each patient will be 10 sessions, spread over 5 weeks, which means a frequency of twice a week. Each NESA microcurrent session will last 60 minutes. A maximum time of 15 minutes will be allowed for connecting the patient at the beginning and for removing the device at the end. The directing electrode will be located throughout the treatment between the spinous processes of C6 and C7 to act generally on the individual, and in later sessions, the electrode will be placed d at T12-S3 to influence the sacral plexus. The intensity will be set to Low (3 volts) in all sessions,. The other device parameters range between 100-900 microamperes and between 1.14 and 14.29 hertz, and are preset by each program.
- Primary Outcome Measures
Name Time Method Quality of life by constipation (CVE-20) 10 minutes Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id
- Secondary Outcome Measures
Name Time Method Sleep Quality 10 minutes Questionnaire
Cardiac Frecuency 5 minutes Measured with WeCardio.
Arterial pressure 5 minutes With Sfigmomanometer