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| Name | Class |
|---|---|
| Dr. Alejandro Molina Cabeza | UNKNOWN |
| Susana Ferrandis Martinez | UNKNOWN |
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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.
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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex | Experimental | 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. After 4 hours they end the last session, a new brain mapping is performed. |
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| Premature Ejaculation participants who take Dapoxetine | Active Comparator | Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping |
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| Placebo Group | Sham Comparator | Participants who do not take medication or receive tRNS sessions |
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| Controls | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Radom Noise Stimulation | Device | tRNS against Dapoxetine in LPE patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Wavelet Changes define Brain Biomarker of LPE | The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes. | 1 month |
| EEG coherence comparing Dapoxetine against tRNS | The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence. | 2-3 months |
| Adverse events comparing Dapoxetine against tRNS | Report adverse events during the application of the protocol Dapoxetine / tRNS. | 2-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls | Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls. | 1 month |
| Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls |
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Inclusion Criteria:
Exclusion Criteria:
All of patients were diagnosed of Longlife Premature Ejaculation
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Molina Cabeza, MD | Sexual Salud Valclinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salud Valclinic | Valencia | 46900 | Spain |
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| Label | URL |
|---|---|
| Sexual Valclinic health Institute | View source |
| Urology Department Hereford Hospital | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 30, 2023 | |
| Reset | Mar 6, 2024 | |
| Release | Mar 8, 2024 |
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Allocation: Randomized Intervention Model: Parallel Assignment
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12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.
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| Take Dapoxetine | Drug | Dapoxetine against tRNS in LPE patients |
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| Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants | Combination Product | Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups. |
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| Compare LPE EEG endophenotype between participants and healthy controls | Diagnostic Test | Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype |
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Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls. |
| 1 month |
| Unrelease | Apr 19, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 30, 2023 | Mar 6, 2024 | |||
| Mar 8, 2024 | Apr 19, 2024 |
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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