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Completed

NCT Number: NCT04850703

Brain Networks Implicated in Lifelong Premature Ejaculation Patients

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.

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Key information

Conditions

Premature Ejaculation Ejaculatory Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

30 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Salud Valclinic

Valencia, 46900, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Radom Noise Stimulation

Device

tRNS against Dapoxetine in LPE patients

Other names: tRNS

Take Dapoxetine

Drug

Dapoxetine against tRNS in LPE patients

Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants

Combination Product

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

Compare LPE EEG endophenotype between participants and healthy controls

Diagnostic Test

Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype

Primary outcomes

  1. Wavelet Changes define Brain Biomarker of LPE

    Time frame: 1 month

    The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.

  2. EEG coherence comparing Dapoxetine against tRNS

    Time frame: 2-3 months

    The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.

  3. Adverse events comparing Dapoxetine against tRNS

    Time frame: 2-3 months

    Report adverse events during the application of the protocol Dapoxetine / tRNS.

Secondary outcomes

  1. Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls

    Time frame: 1 month

    Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.

  2. Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls

    Time frame: 1 month

    Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.

Sponsors and collaborators

Lead sponsor

Moises Domingo

Other

Collaborators

  • Dr. Alejandro Molina Cabeza
  • Susana Ferrandis Martinez

Registry information

Official study 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

Acronym: LPE

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 20, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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