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

NCT06304558 | Completed DMC

• 1 other identifier: CI 240228, 2024-480
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Satisfaction

Outcome Measures

Primary Outcomes (1)

• Sexual satisfaction

  Questionnaire

  10 minutes

Secondary Outcomes (4)

• Stress levels

  10 minutes

• Blood Pressure (Sistolic and diastolic)

  5 minutes

• Heartbeats per minute

  5 minutes

• Sleep Quality

  10 minutes

Study Arms (2)

Intervention

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

Non-active Non-invasive Neuromodulation (NESA)

Device: Non-Invasive Neuromodulation (NESA)

Interventions

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.

Intervention; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects from 18 to 65 years
• Sexually active
• Signed consent form

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Universidad Europea de Madrod

Villaviciosa de Odón, Spain

Location

MeSH Terms

Conditions

Orgasm

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Placebo group will mimic the Intervention group, but the device will not be connected. With this non-invasive neuromodulation, patiens do not experiment any sensation when the device is connected.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 12, 2024
• Study Start: March 30, 2024
• Primary Completion: April 1, 2024
• Study Completion: June 30, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)