Brain Networks Implicated in Lifelong Premature Ejaculation Patients

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04850703

Acronym

LPE

Enrollment

128

Registered

2021-04-20

Start date

2021-02-02

Completion date

2023-02-04

Last updated

2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation, Sexual Dysfunction

Keywords

Brain Mapping, EEG, ERP, tDCS, tRNS, Dapoxetine, Lifelong premature ejaculation, central inhibitory network function, inferior frontal gyrus, dentate nucleus, right frontal pole, Resting State Networks, Funtional connectivity

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.

Interventions

DEVICETranscranial Radom Noise Stimulation

tRNS against Dapoxetine in LPE patients

DRUGTake Dapoxetine

Dapoxetine against tRNS in LPE patients

COMBINATION_PRODUCTComparation 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.

DIAGNOSTIC_TESTCompare 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Masking description

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

Intervention model description

Allocation: Randomized Intervention Model: Parallel Assignment

Eligibility

Sex/Gender

MALE

Age

30 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026