Brain Networks Implicated in Lifelong Premature Ejaculation Patients

Sexual Dysfunction Clinical Trial

— LPE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04850703
• Other study ID #: 0104201UR
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2, 2021
• Est. completion date: February 4, 2023

Study information

• Verified date: April 2023
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 4, 2023
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation
• Sexual Dysfunction

Intervention

Device:
• Transcranial Radom Noise Stimulation
tRNS against Dapoxetine in LPE patients

Drug:
• Take Dapoxetine
Dapoxetine against tRNS in LPE patients

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.

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

Locations

Country	Name	City	State
Spain	Salud Valclinic	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Moises Domingo	Dr. Alejandro Molina Cabeza, Susana Ferrandis Martinez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Adverse events comparing Dapoxetine against tRNS	Report adverse events during the application of the protocol Dapoxetine / tRNS.	2-3 months
Secondary	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
Secondary	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

External Links

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