Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration

Study Overview
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Brief Summary
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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

Detailed Description
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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. Great effort has been assigned for the preservation of visual data to be shared in the investigators' research centre with other researchers internationally. The participant testing platform created for this study allows for a full-proof research ethics anonymous & confidential registry & testing process (triple blind). Aggressive optimum (supra-threshold and below-pain threshold) taVNS is the therapeutic modality of choice in order to examine desire down-regulation effects using taVNS. DSM-V stock participants must be sub-grouped in the paraphilic categorical structure of the DSM-V.

Official Title
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Acute Paraphilic Pathway Down-Regulation In A Specialized Sensitive Group Using taVNS Modulation

Conditions
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Desire; Sexual, Aversion, Paraphilia

Intervention / Treatment
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* Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 to 60 years old - heterosexual identifying as he/him Exclusion Criteria: 35 to 40 age group - heterosexual identifying as he/him

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The sequential study is involved in a translational study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T3 Subgroup<br>Two T3 Subgroups: Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve<br>* Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]<br>|
| Experimental: T5 (Young Adult) Subgroup<br>Two T5 Subgroups Age-Play Subgroup (APSI): Paraphilia with androphilic or gynephilic Tanner 5 SI Marker (Sexual Incitation) | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve<br>* Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]<br>|
| Sham Comparator: Sham Comparator<br>Medical Device Sham Comparator taVGN (Cranial Ten - Vagus Nerve) Selection of Random Participants In Any Subgroup Class Androphilic or gynephilic SI Marker (Sexual Incitation) | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve<br>* Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]<br>|
| Experimental: T2 Subgroup<br>Two T2 Subgroups: Paraphilia with androphilic or gynephilic Tanner 2 SI Marker (Sexual Incitation) | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve<br>* Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]<br>|
| Experimental: T4 Subgroup<br>Two T4 Subgroups: Paraphilia with androphilic or gynephilic Tanner 4 SI Marker (Sexual Incitation) | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve<br>* Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect) | Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium | Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroup | 
| Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)) | Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium | Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T5 subgroup | 
| Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)) | Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium | Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T4 Subgroup | 
| Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)) | Visual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium | Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Down-Regulation, Vagus Cranial Nerve Modulation, Desire Control, taVNS [transcutaneous afferent vagus nerve stimulation]