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OpenTrials
Completed

NCT Number: NCT06304558

"Effectiveness of Non-invasive Neuromodulation Treatment 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Invasive Neuromodulation (NESA)

Device

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.

Primary outcomes

  1. Sexual satisfaction

    Time frame: 10 minutes

    Questionnaire

Secondary outcomes

  1. Stress levels

    Time frame: 10 minutes

    Questionnaire

  2. Blood Pressure (Sistolic and diastolic)

    Time frame: 5 minutes

    Sfignomanometer

  3. Heartbeats per minute

    Time frame: 5 minutes

    We Cardio http://en.wecardio.com/3_1ourmachinepage.html

  4. Sleep Quality

    Time frame: 10 minutes

    Questionnaire

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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