A Phase 1/2 interventional study of Transcranial Radom Noise Stimulation and Take Dapoxetine in Premature Ejaculation and Sexual Dysfunction, sponsored by Moises Domingo. Completed at 1 site in Spain. Open to male participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Moises Domingo · Phase 1/2, Interventional, and Treatment
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 128 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →This is the only study on the registry with Moises Domingo as lead sponsor.
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Exclusion Criteria:
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.
Device: Transcranial Radom Noise Stimulation
Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping
Drug: Take Dapoxetine
Participants who do not take medication or receive tRNS sessions
Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants
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.
Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls
tRNS against Dapoxetine in LPE patients
Also known as: tRNS
Dapoxetine against tRNS in LPE patients
Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype
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.
Time frame: 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.
Time frame: 2-3 months
Adverse events comparing Dapoxetine against tRNS
Report adverse events during the application of the protocol Dapoxetine / tRNS.
Time frame: 2-3 months
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.
Time frame: 1 month
Measure the effect of tRNS through ERP Novelty Wave changes 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 tRNS group against controls.
Time frame: 1 month
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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