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Brain Networks Implicated in Lifelong Premature Ejaculation Patients (LPE)

Primary Purpose

Premature Ejaculation, Sexual Dysfunction

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Transcranial Radom Noise Stimulation
Take Dapoxetine
Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants
Compare LPE EEG endophenotype between participants and healthy controls
Sponsored by
Moises Domingo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring 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

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Salud Valclinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Sham Comparator

Other

Arm Label

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

Premature Ejaculation participants who take Dapoxetine

Placebo Group

Controls

Arm 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.

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

Participants who do not take medication or receive tRNS sessions

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 7, 2021
Last Updated
April 10, 2023
Sponsor
Moises Domingo
Collaborators
Dr. Alejandro Molina Cabeza, Susana Ferrandis Martinez
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1. Study Identification

Unique Protocol Identification Number
NCT04850703
Brief Title
Brain Networks Implicated in Lifelong Premature Ejaculation Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
May 21, 2022 (Actual)
Study Completion Date
February 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moises Domingo
Collaborators
Dr. Alejandro Molina Cabeza, Susana Ferrandis Martinez

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Allocation: Randomized Intervention Model: Parallel Assignment
Masking
Care ProviderInvestigator
Masking Description
12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premature Ejaculation participants who receive Brain Weak Currents in IFG brain cortex
Arm Type
Experimental
Arm 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.
Arm Title
Premature Ejaculation participants who take Dapoxetine
Arm Type
Active Comparator
Arm Description
Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping
Arm Title
Placebo Group
Arm Type
Sham Comparator
Arm Description
Participants who do not take medication or receive tRNS sessions
Arm Title
Controls
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Transcranial Radom Noise Stimulation
Other Intervention Name(s)
tRNS
Intervention Description
tRNS against Dapoxetine in LPE patients
Intervention Type
Drug
Intervention Name(s)
Take Dapoxetine
Intervention Description
Dapoxetine against tRNS in LPE patients
Intervention Type
Combination Product
Intervention Name(s)
Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants
Intervention Description
Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
Intervention Type
Diagnostic Test
Intervention Name(s)
Compare LPE EEG endophenotype between participants and healthy controls
Intervention Description
Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype
Primary Outcome Measure Information:
Title
Wavelet Changes define Brain Biomarker of LPE
Description
The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.
Time Frame
1 month
Title
EEG coherence comparing Dapoxetine against tRNS
Description
The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.
Time Frame
2-3 months
Title
Adverse events comparing Dapoxetine against tRNS
Description
Report adverse events during the application of the protocol Dapoxetine / tRNS.
Time Frame
2-3 months
Secondary Outcome Measure Information:
Title
Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls
Description
Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in Dapoxetine group against controls.
Time Frame
1 month
Title
Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls
Description
Changes in latencies and amplitude of Novelty wave in the Ventro-lateral prefrontal cortex comparing novelty wave in tRNS group against controls.
Time Frame
1 month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
All of patients were diagnosed of Longlife Premature Ejaculation
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Molina Cabeza, MD
Organizational Affiliation
Sexual Salud Valclinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salud Valclinic
City
Valencia
ZIP/Postal Code
46900
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://saludsexualvalclinic.com/
Description
Sexual Valclinic health Institute
URL
http://herefordshireurology.co.uk/
Description
Urology Department Hereford Hospital

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Brain Networks Implicated in Lifelong Premature Ejaculation Patients

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