Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Phase 1

Completed

• Conditions: Sexual Dysfunction; Premature Ejaculation
• Interventions: Device: Transcranial Radom Noise Stimulation; Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants; Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls; Drug: Take Dapoxetine

• Registration Number: NCT04850703
• Lead Sponsor: Moises Domingo

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-02-02
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-20
• Primary Completion: 2022-05-21
• Study Completion: 2023-02-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 128

Inclusion Criteria

• To be over 18 years old and less than 70 years
• Best-practice diagnosed Longlife Premature ejaculation
• Diagnosed since at least one years prior to enrollment.
• No use drugs or medicines

Exclusion Criteria

• Serious visual and hearing loss
• Brain injury following cranial trauma
• Other neurological disorders like Parkinson, ME, headache, etc.
• Birth trauma
• Mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex	Transcranial Radom Noise Stimulation	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.
Placebo Group	Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants	Participants who do not take medication or receive tRNS sessions
Controls	Compare LPE EEG endophenotype between participants and healthy controls	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.
Premature Ejaculation participants who take Dapoxetine	Take Dapoxetine	Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping

Primary Outcome Measures

Name	Time	Method
Wavelet Changes define Brain Biomarker of LPE	1 month	The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.
Adverse events comparing Dapoxetine against tRNS	2-3 months	Report adverse events during the application of the protocol Dapoxetine / tRNS.
EEG coherence comparing Dapoxetine against tRNS	2-3 months	The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.

Secondary Outcome Measures

Name	Time	Method
Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls	1 month	Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.
Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls	1 month	Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.

Trial Locations

Locations (1)

Salud Valclinic; 🇪🇸 Valencia, Spain