Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Moises Domingo128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

128

Conditions

Premature Ejaculation Sexual Dysfunction

Interventions

Transcranial Radom Noise StimulationDEVICE

tRNS against Dapoxetine in LPE patients

Take DapoxetineDRUG

Dapoxetine against tRNS in LPE patients

Comparation EEG changes between Sham Group against tRNS and Dapoxetin participantsCOMBINATION_PRODUCT

Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.

Eligibility

Sex: MALEMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Salud Valclinic

Valencia, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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