"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.

Sexual Satisfaction Clinical Trial

Official title:

"Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for Improving Sexual Satisfaction in Healthy Subjects.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304558
• Other study ID #: CI 240228, 2024-480
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects from 18 to 65 years

• Sexually active

• Signed consent form

Exclusion Criteria:

• 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.

• Minors.

• Individuals who have previously received any type of neuromodulation treatment.

• Cancer.

Related Conditions & MeSH terms

• Sexual Satisfaction

Intervention

Device:
• Non-Invasive Neuromodulation (NESA)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual satisfaction	Questionnaire	10 minutes
Secondary	Stress levels	Questionnaire	10 minutes
Secondary	Blood Pressure (Sistolic and diastolic)	Sfignomanometer	5 minutes
Secondary	Heartbeats per minute	We Cardio http://en.wecardio.com/3_1ourmachinepage.html	5 minutes
Secondary	Sleep Quality	Questionnaire	10 minutes