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

NCT ID: NCT06304558

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2024-06-30

Brief 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.

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.

Conditions

Sexual Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Non-Invasive Neuromodulation (NESA)

Intervention Type: 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.

Placebo

Non-active Non-invasive Neuromodulation (NESA)

Group Type: PLACEBO_COMPARATOR

Non-Invasive Neuromodulation (NESA)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Vanesa Abuín

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Europea de Madrod

Villaviciosa de Odón, , Spain

Countries

Spain

Other Identifiers

CI 240228, 2024-480

Identifier Type: -

Identifier Source: org_study_id