Clinical trial NCT04850703: Brain Networks Implicated in Lifelong Premature Ejaculation Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
Lead sponsor: Spanish Foundation for Neurometrics Development
Sponsor class: OTHER
Collaborators: name: Dr. Alejandro Molina Cabeza
name: Susana Ferrandis Martinez
First posted: 2021-04-20
Enrollment: 128
Sex: MALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wavelet Changes define Brain Biomarker of LPE
timeFrame: 1 month
measure: EEG coherence comparing Dapoxetine against tRNS
timeFrame: 2-3 months
measure: Adverse events comparing Dapoxetine against tRNS
timeFrame: 2-3 months
Secondary outcomes:
measure: Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls
timeFrame: 1 month
measure: Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls
timeFrame: 1 month
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Salud Valclinic
Study officials:
affiliation: Sexual Salud Valclinic
name: Alejandro Molina Cabeza, MD
role: PRINCIPAL_INVESTIGATOR
References: