Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Efficacy of tDCS in treatment of craving of sexual addiction
研究概览
简要总结
In patients with addiction to a substance, an increase in activity in the prefrontal cortex induced by transcranial Direct Current Stimulation -tDCS (non-invasive technique, modulating cortical activity by applying low-intensity electrical currents between two electrodes),may help reduce craving in people addicted to alcohol and tobacco. By analogy with addictive behavior with a substance, the craving observed in certain behavioral addictions would involve the same neural circuits.
The main hypothesis is to reduce the sexual craving associated with the viewing of erotic images during active brain stimulation compared to placebo stimulation. Functional MRI will allow to better understand the neural circuits involved in sexual addiction and in the expected inhibition of sexual arousal by tDCS in sexual addictions during visualization erotic images.
详细描述
The concept of sexual addiction appeared in American literature about 20 years ago. The term sexual addiction describes an excessive, increasing, and especially uncontrolled frequency of sexual behavior, as a conventional rule, associated with a compelling and irrepressible sexual desire (craving), which persists in spite of the possible negative consequences and personal suffering of the subject. The prevalence of this condition is estimated to be approximately 3-6% in the general population in the United States, it is independent of the socio-cultural environment. The pathophysiology of sexual addictions remains very poorly understood.
Numerous studies have focused on substance addictions and their pathophysiology. The mesolimbic dopaminergic system plays a major role in addictive behavior. The prefrontal cortex and the basolateral region of the amygdala play an important role in the craving and may cause relapse in subjects. In subjects with sexual addiction, only one controlled study has been conducted on the role of antidepressant treatment in the reduction of craving. The objective of the study is not only to evaluate the efficacy of tDCS neurostimulation in this disorder but also to identify the brain structures involved in this addictive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Depending on the randomized group, the subject will receive one of two treatments 15 days apart (A: active anode on the right DLPFC and neutral cathode on the left shoulder; B: inactive anode on the DLPFC and inactive cathode on the left shoulder). The groups are defined as follows:
The results of randomization will not be known by the evaluator.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-60 year old male
- •Heterosexual
- •Right-handed (Manual laterality test)
- •With a sexual addiction (PEACCE Tool> 3 and Carnes ≥ 13/25) except for controls
- •Having signed a written and informed consent
- •Subject benefiting from social security
排除标准
- •Subject presenting a medical pathology requiring drug treatment,
- •Severe psychiatric pathology (bipolar disorder, hyperactivity or schizophrenia) or another addiction (alcohol, illicit substances or behavioral addiction)
- •Subject consuming psychotropic drugs in progress or during the last month
- •Subject not understanding French
- •Subject under tutorship or curatorship
- •Subjects with neurological disease including epilepsy or a history of head trauma
- •Subjects hospitalized in enforced hospitalization
- •Subject presenting a contraindication to tDCS: subject with an electrical or metal brain implant
- •Subject with a contraindication to MRI
结局指标
主要结局
Efficacy of tDCS in treatment of craving of sexual addiction
时间窗: 3 years
The primary outcome is to assess the effectiveness of tDCS treatment on the reduction of the craving by comparing before and after active tDCS stimulation in response to erotic-pornographic images. Efficacy will be quantified by a sexual craving scale associated with erotico-pornographic images before and after tDCS stimulation. A significant decrease in craving and score on the scale is expected after tDCS stimulation. compared to control subjects. Images of social and neutral interactions will be used as comparison of expected changes. The scale used is the PATHOS scale: brief sexual addiction screening questionnaire.
Efficacy of tDCS in treatment of sexual addiction in subjective emotional response
时间窗: 3 years
For the evaluation of efficacy of tDCS in emotional response, indirect measurement of craving, visual emotional responses scales (Likert) will be used during visualization of erotico-pornographic images, before and after stimulation. The "desire" will be quantified on a Likert scale from 0 to 7.
Efficacy of tDCS in treatment of sexual addiction in objective emotional response
时间窗: 3 years
An assessment of emotional responses will also be done using heart rate measure during visualization of images in fMRI, before and after stimulation by tDCS
次要结局
- Evaluation Evaluation of Impulsivity with Stop Signal Task(3 years)
- Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale(3 years)
- Brain structures involved in sexual addiction(3 years)
- Evaluation of Impulsivity with The Barratt Impulsiveness Scale(3 years)