Sexual SatisfactionNCT06304558
"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.
A study testing Non-Invasive Neuromodulation (NESA) in people with Sexual Satisfaction, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Satisfaction
- What is being tested?
- Non-Invasive Neuromodulation (NESA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2024to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects from 18 to 65 years
- Sexually active
- Signed consent form
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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.
Read the 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
- Being tested
- Non-Invasive Neuromodulation (NESA)
- Medical subject headings
- Orgasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Non-Invasive Neuromodulation (NESA) |
| Placebo | Placebo comparator | Non-active Non-invasive Neuromodulation (NESA) Receives: Device: Non-Invasive Neuromodulation (NESA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual satisfaction
Questionnaire
Measured: 10 minutes
Secondary outcomes (4)
Stress levels
Questionnaire
Measured: 10 minutes
Blood Pressure (Sistolic and diastolic)
Sfignomanometer
Measured: 5 minutes
Heartbeats per minute
We Cardio http://en.wecardio.com/3_1ourmachinepage.html
Measured: 5 minutes
Sleep Quality
Questionnaire
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Mar 2024
- Primary completion1 Apr 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanesa Abuín, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304558
- Sponsor's protocol ID
- CI 240228, 2024-480
- Status last verified
- Dec 2024
- First submitted
- 19 Feb 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for Improving Sexual Satisfaction in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT06304558
- Acronym / sponsor ID
- CI 240228, 2024-480
- Conditions
- Sexual Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Non-Invasive Neuromodulation (NESA)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 |
| Placebo | Placebo comparator | Device: Non-Invasive Neuromodulation (NESA)Non-active Non-invasive Neuromodulation (NESA) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects from 18 to 65 years
- Sexually active
- Signed consent form
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention, Placebo |
Primary outcome
Sexual satisfaction
Time frame: 10 minutes
Questionnaire
4 secondary outcomes
Stress levels
Time frame: 10 minutes
Blood Pressure (Sistolic and diastolic)
Time frame: 5 minutes
Heartbeats per minute
Time frame: 5 minutes
Sleep Quality
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Neuromodulation (NESA) in people with Sexual Satisfaction, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual satisfaction (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.