LPE: Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Sponsor

Moises Domingo (Other)

Overall Status

Recruiting

CT.gov ID

NCT04850703

Collaborator

Dr. Alejandro Molina Cabeza (Other), Susana Ferrandis Martinez (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation Sexual Dysfunction	Device: Transcranial Radom Noise Stimulation Drug: Take Dapoxetine Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Allocation: Randomized Intervention Model: Parallel AssignmentAllocation: Randomized Intervention Model: Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 2, 2021

Anticipated Primary Completion Date :

May 21, 2021

Anticipated Study Completion Date :

Jun 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex 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 tRNS against Dapoxetine in LPE patients Other Names: tRNS
Active Comparator: Premature Ejaculation participants who take Dapoxetine Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping	Drug: Take Dapoxetine Dapoxetine against tRNS in LPE patients
Sham Comparator: Placebo Group Participants who do not take medication or receive tRNS sessions	Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
Other: 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.	Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype

Outcome Measures

Primary Outcome Measures

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.
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.
Adverse events comparing Dapoxetine against tRNS [2-3 months]
Report adverse events during the application of the protocol Dapoxetine / tRNS.

Secondary Outcome Measures

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.