Acute Paraphilic Pathway Down-Regulation In A Specialized Sensitive Group Using taVNS Modulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))
研究概览
简要总结
Transcutaneous Afferent Vagus Nerve Stimulation [taVNS] is used to modulate persistent & intense desire control amongst a specific participant group.
Testing Center Order of Deliver Number
详细描述
taVNS Diagnostic Spectrum Testing Center Order of Delivery
-
- Addiction - Opioid
-
- Chronic Pain - Central
-
- Anxiety + Panic Disorder
-
- MDD - Major Depression Disorder
-
- Addiction - Nicotine
-
- ADHD
-
- Addiction - Stimulant
-
- Addiction - Sexual + Love
-
- Addiction - Paraphilia
-
- Parkinsons
-
- Immune Enhancing
-
- Addiction - Overeating
RE-ORDERED CLINICAL TRIAL - NINE
Physiologic effects of taVNS stimulation have been extensively researched for over 150 years. Drug-resistant depression (MDD), migraine headaches, pelvic pain modulation, facilitation of motor learning in neonates, post stroke rehabilitation and seizures are some of the conditions investigated with favorable results using taVNS intervention. taVNS physiologic & mental effects have been noted to have advantageous therapeutic results on a vast diagnostic spectrum.
A clinical testing program for pre- and post-test was devised as a means to identify & measure treatment effects in specific T3, 4 and early 5 (Tanner) sub-group visual stimulation. The programmatic (software) of the stimulation medium created for this study is aimed to abate the use of a phallometric device purposed to measure sexual stimulation effects on participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Anonymity of participants is allowed for by using a participant computed platform assigning random visual stimulation sequences, thereby mixing Visual Inducer Test Media (T3, 4 & 5 (Young Adult)). The laboratory observer, software identification of participants, investigators, assessors & care providers are blinded in the software testing phase of the study.
The taVNS intervention is also triple blinded (participant sham intervention, observer, care provider, investigators & assessors).
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •21 to 60 years old - heterosexual identifying as he/him
排除标准
- •35 to 40 age group - heterosexual identifying as he/him
结局指标
主要结局
Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))
时间窗: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup
Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium
Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)
时间窗: Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroup
Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium
次要结局
未报告次要终点
研究者
Dr. Michel Rice
Associate Academic Dean Faculty of Medicine, Dean Research Department MD-PhD Program Faculty of Medicine
American University Of Montserrat