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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Adverse events comparing Dapoxetine against tRNS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
12 patients will be receive tRNS sham 10 sessions. 12 patients will take Dapoxetine, sham 10.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Serious visual and hearing loss
- •Brain injury following cranial trauma
- •Other neurological disorders like Parkinson, ME, headache, etc.
- •Birth trauma
- •Mental retardation
研究组 & 干预措施
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.
干预措施: Transcranial Radom Noise Stimulation (Device)
Premature Ejaculation participants who take Dapoxetine
Participants take 1 tablet of the drug between 1 and 3 hours before the brain mapping
干预措施: Take Dapoxetine (Drug)
Placebo Group
Participants who do not take medication or receive tRNS sessions
干预措施: Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants (Combination Product)
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.
干预措施: Compare LPE EEG endophenotype between participants and healthy controls (Diagnostic Test)
结局指标
主要结局
Adverse events comparing Dapoxetine against tRNS
时间窗: 2-3 months
Report adverse events during the application of the protocol Dapoxetine / tRNS.
Wavelet Changes define Brain Biomarker of LPE
时间窗: 1 month
The investigators will reported changes in wavelet (time-frequencies) in Left Prefrontal Lobe F3, F7 and Fz electrodes.
EEG coherence comparing Dapoxetine against tRNS
时间窗: 2-3 months
The investigators will reported changes in brain connectivity comparing taking Dapoxetine with the use of tRNS, calculating EEG coherence.
次要结局
- Measure the effect of Dapoxetine through ERP Novelty Wave comparing with the values of the controls(1 month)
- Measure the effect of tRNS through ERP Novelty Wave changes comparing with the values of the controls(1 month)
研究者
Moises Domingo
Sub Investigator
Spanish Foundation for Neurometrics Development