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

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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Satisfaction
• Intervention / Treatment: Device: Non-Invasive Neuromodulation (NESA)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Villaviciosa de Odón, Spain
    • Universidad Europea de Madrod

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Placebo Comparator: Placebo; Non-active Non-invasive Neuromodulation (NESA)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual satisfaction	Questionnaire	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Quality	Questionnaire	10 minutes
Stress levels	Questionnaire	10 minutes
Blood Pressure (Sistolic and diastolic)	Sfignomanometer	5 minutes
Heartbeats per minute	We Cardio http://en.wecardio.com/3_1ourmachinepage.html	5 minutes

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 8, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CI 240228, 2024-480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No