Brain Networks Implicated in Lifelong Premature Ejaculation Patients

NCT04850703 | Completed Phase 1 DMC

• 1 other identifier: 0104201UR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  2-3 months

• Adverse events comparing Dapoxetine against tRNS

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

  2-3 months

Secondary Outcomes (2)

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

  1 month

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

  1 month

Study Arms (4)

Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex

EXPERIMENTAL

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

Premature Ejaculation participants who take Dapoxetine

ACTIVE COMPARATOR

Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping

Drug: Take Dapoxetine

Placebo Group

SHAM COMPARATOR

Participants who do not take medication or receive tRNS sessions

Combination Product: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants

Controls

OTHER

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

Interventions

Transcranial Radom Noise Stimulation DEVICE

tRNS against Dapoxetine in LPE patients

Also known as: tRNS

Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex

Take Dapoxetine DRUG

Dapoxetine against tRNS in LPE patients

Premature Ejaculation participants who take Dapoxetine

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.

Placebo Group

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

Controls

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: All of patients were diagnosed of Longlife Premature Ejaculation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Moises Domingo: lead
• Dr. Alejandro Molina Cabeza: collaborator
• Susana Ferrandis Martinez: collaborator

Study Sites (1)

Salud Valclinic

Valencia, 46900, Spain

Location

Related Links

• Sexual Valclinic health Institute
• Urology Department Hereford Hospital

MeSH Terms

Conditions

Premature Ejaculation; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Alejandro Molina Cabeza, MD

  Sexual Salud Valclinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub Investigator

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 20, 2021
• Study Start: February 2, 2021
• Primary Completion: May 21, 2022
• Study Completion: February 4, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)