Brain Networks Implicated in Lifelong Premature Ejaculation Patients (LPE)

Moises Domingo

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sexual Dysfunction; Premature Ejaculation

Treatments: 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; Device: Transcranial Radom Noise Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04850703

0104201UR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Transcranial Radom Noise Stimulation

Premature Ejaculation participants who take Dapoxetine

Active Comparator group

Description:

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

Treatment:

Drug: Take Dapoxetine

Placebo Group

Sham Comparator group

Description:

Participants who do not take medication or receive tRNS sessions

Treatment:

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

Controls

Other group

Description:

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.

Treatment:

Diagnostic Test: Compare LPE EEG endophenotype between participants and healthy controls