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

NCT06304558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Sexual Satisfaction

Interventions

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.

Sponsors & Collaborators

  • Universidad Europea de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-30
Primary Completion
2024-04-01
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304558 on ClinicalTrials.gov