Clinical trial NCT05482412: Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration
Official title: Acute Paraphilic Pathway Down-Regulation In A Specialized Sensitive Group Using taVNS Modulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Desire; Sexual, Aversion
Paraphilia
Keywords: Down-Regulation
Vagus Cranial Nerve Modulation
Desire Control
taVNS [transcutaneous afferent vagus nerve stimulation]
Lead sponsor: American University Of Montserrat
Sponsor class: OTHER
Collaborators: name: Greg Thomas William Consultant Research, Queens University
name: Irene Becker Consultant, Coaching Certification for Pain Management
name: Susan Jones MD PhD
name: Peter Martin BSc Forensic Psych, Masters in Education, JPH Internal Meds + Family Meds Rotation Teaching Assistant
name: Kofi McNair Nyamekye B Eng. Op. Neuromod. Masters + 4th Yr Meds Student
First posted: 2022-08-01
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The sequential study is involved in a translational study.
Primary purpose: TREATMENT

Brief summary: 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: taVNS Diagnostic Spectrum Testing Center Order of Delivery

1. - Addiction - Opioid
2. - Chronic Pain - Central
3. - Anxiety + Panic Disorder
4. - MDD - Major Depression Disorder
5. - Addiction - Nicotine
6. - ADHD
7. - Addiction - Stimulant
8. - Addiction - Sexual + Love
9. - Addiction - Paraphilia
10. - Parkinsons
11. - Immune Enhancing
12. - 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.

Eligibility criteria: Inclusion Criteria:

* 21 to 60 years old - heterosexual identifying as he/him

Exclusion Criteria:

* 35 to 40 age group - heterosexual identifying as he/him

Primary outcomes:
measure: Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)
timeFrame: Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroup
measure: Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))
timeFrame: Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T5 subgroup
measure: Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))
timeFrame: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T4 Subgroup
measure: Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect))
timeFrame: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup
Secondary outcomes:
Other outcomes:
measure: Self-Reported Questionnaire
timeFrame: Day 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatment
measure: Self-Reported Questionnaire
timeFrame: Day 1 Measured immediately post VITM but post taVNS treatment
measure: Self-Reported Questionnaire
timeFrame: Day 10 - After 10 treatments within 2 weeks) Measure immediately post VITM but post taVNS treatment
Locations:
Study officials:
affiliation: CEO AUM
name: Athavan Gananathan, MD
role: STUDY_DIRECTOR
References: