"Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for Improving Sexual Satisfaction in Healthy Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sexual satisfaction
研究概览
简要总结
The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.
As secondary objectives, the effectiveness of the XSignal device during a defined treatment period will be analyzed in terms of quality of life, pain, stress, anxiety, sexual function, sleep quality, cortisol, heart rate, blood pressure, respiratory rate, and body temperature of the same subjects, compared with a placebo group, observing the long-term influence of the results.
详细描述
Considering the objectives set: In the first phase, the directing electrode will be located at C6-C7 to generate a systemic and general effect on the organism, with program 1, program 2, program 7, and program 8. In the second phase, the directing electrode will be placed at the abdominal level in the area of the mesenteric plexus to influence the sympathetic innervation of the viscera. In the third phase, the directing electrode is located at S2-S3 to concentrate the action of the therapy on the sacral parasympathetic plexus,. In this way, both the sympathetic and parasympathetic innervation of the main sexual organs are covered through the sympathetic paravertebral ganglia and the sacral plexus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected.
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
- •Subjects from 18 to 65 years
- •Sexually active
- •Signed consent form
排除标准
- •Diagnosed diseases.
- •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
Intervention
T 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.
During the 10 sessions of the treatment, the programming will evolve to optimize the response.
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 in the abdominal area to cover the hypogastric plexus and at S2-S3 to influence the sacral plexus.
The intensity will be set to Low (3 volts) in all sessions, following the Arndt-Schulz law. 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)
Placebo
Non-active Non-invasive Neuromodulation (NESA)
干预措施: Non-Invasive Neuromodulation (NESA) (Device)
结局指标
主要结局
Sexual satisfaction
时间窗: 10 minutes
Questionnaire
次要结局
- Sleep Quality(10 minutes)
- Blood Pressure (Sistolic and diastolic)(5 minutes)
- Stress levels(10 minutes)
- Heartbeats per minute(5 minutes)
研究者
Vanesa Abuín
Associated Professor
Universidad Europea de Madrid