Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for the Management of Constipation Without Diagnosed Pathology in Students of the European University of Madrid (Spain)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Quality of life by constipation (CVE-20)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The device will be placed with no current. This type of neuromodulation gives no feeling at all to the patient while administred, so there is no way for the patient to know if the apparatus is connected or not.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants from 18 to 65 years old
- •Sign informed consent
排除标准
- •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.
- •Individuals who have previously received any type of neuromodulation treatment.
研究组 & 干预措施
Placebo
Non-active Non-Invasive Neuromodulation NESA
干预措施: Non-Invasive Neuromodulation NESA (Device)
Intervention
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.
干预措施: Non-Invasive Neuromodulation NESA (Device)
结局指标
主要结局
Quality of life by constipation (CVE-20)
时间窗: 10 minutes
Questionnaire. https://www.sciencedirect.com/science/article/abs/pii/S0025775308722851#aep-article-footnote-id
次要结局
- Sleep Quality(10 minutes)
- Cardiac Frecuency(5 minutes)
- Arterial pressure(5 minutes)
研究者
Vanesa Abuín
Associated Professor
Universidad Europea de Madrid