Brain Networks Implicated in Lifelong Premature Ejaculation Patients (LPE)

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

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.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Premature Ejaculation
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: MOISES AGUILAR-DOMINGO, PhD; Phone Number: +447940810368; Email: drmoisesaguilar@gmail.com
• Study Contact Backup: Name: Susana Ferrandis Martinez, MD; Phone Number: +34630501290; Email: susana2devel@gmail.com

Study Locations

• Spain
  • Valencia, Spain, 46900
    • Salud Valclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 month

Collaborators and Investigators

• Sponsor: Moises Domingo
• Collaborators: Dr. Alejandro Molina Cabeza; Susana Ferrandis Martinez
• Investigators: Principal Investigator: Alejandro Molina Cabeza, MD, Sexual Salud Valclinic

Publications and helpful links

Helpful Links

• Sexual Valclinic health Institute
• Urology Department Hereford Hospital
• Bigdata4brain LTD

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Actual): May 21, 2022
• Study Completion (Actual): February 4, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: tDCS; EEG; Dapoxetine; tRNS; Brain Mapping; ERP; Lifelong premature ejaculation; central inhibitory network function; inferior frontal gyrus; dentate nucleus; right frontal pole; Resting State Networks; Funtional connectivity
• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: 0104201UR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No