Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT06304558
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2024-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009948', 'term': 'Orgasm'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2024-02-19', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual satisfaction', 'timeFrame': '10 minutes', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Stress levels', 'timeFrame': '10 minutes', 'description': 'Questionnaire'}, {'measure': 'Blood Pressure (Sistolic and diastolic)', 'timeFrame': '5 minutes', 'description': 'Sfignomanometer'}, {'measure': 'Heartbeats per minute', 'timeFrame': '5 minutes', 'description': 'We Cardio http://en.wecardio.com/3\\_1ourmachinepage.html'}, {'measure': 'Sleep Quality', 'timeFrame': '10 minutes', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexual Satisfaction']}, 'descriptionModule': {'briefSummary': 'The main objectives of the programming with the XSignal device will be to influence the sexual satisfaction of the participants.\n\nAs 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects from 18 to 65 years\n* Sexually active\n* Signed consent form\n\nExclusion Criteria:\n\n* Diagnosed diseases.\n* Severe previous psychiatric conditions.\n* Medical contraindications that prevent the use of non-invasive neuromodulation therapy.\n* Having exercised in the hours prior to the NESA treatment.\n* Having consumed coffee or tobacco in the hours prior to the treatment.\n* Minors.\n* Individuals who have previously received any type of neuromodulation treatment.\n* Cancer.'}, 'identificationModule': {'nctId': 'NCT06304558', 'briefTitle': '"Effectiveness of Non-invasive Neuromodulation Treatment for Improving Sexual Satisfaction in Healthy Subjects.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Europea de Madrid'}, 'officialTitle': '"Effectiveness of Non-invasive Neuromodulation Treatment (NESA) for Improving Sexual Satisfaction in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'CI 240228, 2024-480'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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.\n\nEach 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.\n\nDuring the 10 sessions of the treatment, the programming will evolve to optimize the response.\n\nThe 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.\n\nThe 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', 'interventionNames': ['Device: Non-Invasive Neuromodulation (NESA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Non-active Non-invasive Neuromodulation (NESA)', 'interventionNames': ['Device: Non-Invasive Neuromodulation (NESA)']}], 'interventions': [{'name': 'Non-Invasive Neuromodulation (NESA)', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Intervention', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Villaviciosa de Odón', 'country': 'Spain', 'facility': 'Universidad Europea de Madrod', 'geoPoint': {'lat': 40.3581, 'lon': -3.9043}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Europea de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Vanesa Abuín', 'investigatorAffiliation': 'Universidad Europea de Madrid'}}}}