Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT04850703
Status:
COMPLETED
Last Update Posted:
2023-04-12
First Post:
2021-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Networks Implicated in Lifelong Premature Ejaculation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-06', 'releaseDate': '2023-07-30'}, {'releaseDate': '2024-03-08', 'unreleaseDate': '2024-04-19'}], 'estimatedResultsFirstSubmitDate': '2023-07-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D061686', 'term': 'Premature Ejaculation'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000097910', 'term': 'Ejaculatory Dysfunction'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': '12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation: Randomized Intervention Model: Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wavelet Changes define Brain Biomarker of LPE', 'timeFrame': '1 month', 'description': 'The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.'}, {'measure': 'EEG coherence comparing Dapoxetine against tRNS', 'timeFrame': '2-3 months', 'description': 'The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.'}, {'measure': 'Adverse events comparing Dapoxetine against tRNS', 'timeFrame': '2-3 months', 'description': 'Report adverse events during the application of the protocol Dapoxetine / tRNS.'}], 'secondaryOutcomes': [{'measure': 'Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls', 'timeFrame': '1 month', 'description': 'Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.'}, {'measure': 'Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls', 'timeFrame': '1 month', 'description': 'Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Mapping', 'EEG', 'ERP', 'tDCS', 'tRNS', 'Dapoxetine', 'Lifelong premature ejaculation', 'central inhibitory network function', 'inferior frontal gyrus', 'dentate nucleus', 'right frontal pole', 'Resting State Networks', 'Funtional connectivity'], 'conditions': ['Premature Ejaculation', 'Sexual Dysfunction']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://saludsexualvalclinic.com/', 'label': 'Sexual Valclinic health Institute'}, {'url': 'http://herefordshireurology.co.uk/', 'label': 'Urology Department Hereford Hospital'}]}, 'descriptionModule': {'briefSummary': 'Using Brain Mapping and Cognitive ERPs, the investigatos have searched for a Brain Networks involved during Inhibitory Control in Lifelong Premature Ejaculation (LPE) participants. The investigators have designed a clinical trial comparing placebo with tDCS and blacebo group against Dapoxetine, studying the effects on LPE, as well as side effects and their medium and long-term duration.', 'detailedDescription': 'Lifelong premature ejaculation (LPE) is a very common male sexual dysfunction like erectile dysfunction. It produces great distress to sexual harmony and even fertility. Previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (IFG) activation during successful inhibition. If we use the left IFG as a seed, participants showed weaker resting-state functional connectivity (FC) activity, between the seed and two areas (left dentate nucleus (DN) and right frontal pole) compared with controls.\n\nThe main goal is to compare whether the brain biomarker only exists in participants with LPD and how it responds to treatment with Dapoxetine and with tDCS against the IFG networks and lDN, measuring the connectivity changes in these brain networks and FC.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'All of patients were diagnosed of Longlife Premature Ejaculation', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be over 18 years old and less than 70 years\n* Best-practice diagnosed Longlife Premature ejaculation\n* Diagnosed since at least one years prior to enrollment.\n* No use drugs or medicines\n\nExclusion Criteria:\n\n* Serious visual and hearing loss\n* Brain injury following cranial trauma\n* Other neurological disorders like Parkinson, ME, headache, etc.\n* Birth trauma\n* Mental retardation'}, 'identificationModule': {'nctId': 'NCT04850703', 'acronym': 'LPE', 'briefTitle': 'Brain Networks Implicated in Lifelong Premature Ejaculation Patients', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Foundation for Neurometrics Development'}, 'officialTitle': 'Comparative Study of the Clinical Response Between tDCS and Dapoxetine, Define a Very Effective Therapeutic Target, That Improves the LPE in the Medium Long Term', 'orgStudyIdInfo': {'id': '0104201UR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex', 'description': 'Participants receive tRNS (weak currents \\< 2 mA) sessions at IFG brain cortex for 25 minutes 2 times a day 3 times per week during 3 weeks.\n\nAfter 4 hours they end the last session, a new brain mapping is performed.', 'interventionNames': ['Device: Transcranial Radom Noise Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Premature Ejaculation participants who take Dapoxetine', 'description': 'Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping', 'interventionNames': ['Drug: Take Dapoxetine']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo Group', 'description': 'Participants who do not take medication or receive tRNS sessions', 'interventionNames': ['Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants']}, {'type': 'OTHER', 'label': 'Controls', 'description': '44 Healthy humans not clinically not diagnosed with LPD and withouth expression the LPE endophenotype. In this way, the investigators what would be the patients diagnosed clinically with LPE who present the endophenotype or neurophysiological biomarker of LPE.', 'interventionNames': ['Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls']}], 'interventions': [{'name': 'Transcranial Radom Noise Stimulation', 'type': 'DEVICE', 'otherNames': ['tRNS'], 'description': 'tRNS against Dapoxetine in LPE patients', 'armGroupLabels': ['Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex']}, {'name': 'Take Dapoxetine', 'type': 'DRUG', 'description': 'Dapoxetine against tRNS in LPE patients', 'armGroupLabels': ['Premature Ejaculation participants who take Dapoxetine']}, {'name': 'Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants', 'type': 'COMBINATION_PRODUCT', 'description': 'Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.', 'armGroupLabels': ['Placebo Group']}, {'name': 'Compare LPE EEG endophenotype between participants and healthy controls', 'type': 'DIAGNOSTIC_TEST', 'description': 'Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46900', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Salud Valclinic', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Alejandro Molina Cabeza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sexual Salud Valclinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moises Domingo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. Alejandro Molina Cabeza', 'class': 'UNKNOWN'}, {'name': 'Susana Ferrandis Martinez', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sub Investigator', 'investigatorFullName': 'Moises Domingo', 'investigatorAffiliation': 'Spanish Foundation for Neurometrics Development'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-30', 'type': 'RELEASE'}, {'date': '2024-03-06', 'type': 'RESET'}, {'date': '2024-03-08', 'type': 'RELEASE'}, {'date': '2024-04-19', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'Moises Domingo, Main Investigator, Spanish Foundation for Neurometrics Development'}}}}