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

American University Of Montserrat

Status: Not yet enrolling

Conditions: Paraphilia; Desire; Sexual, Aversion

Treatments: Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT05482412

PHD1002

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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100 participants in 5 patient groups

T3 Subgroup

Experimental group

Description:

Two T3 Subgroups: Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation

Treatment:

Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

T5 (Young Adult) Subgroup

Experimental group

Description:

Two T5 Subgroups Age-Play Subgroup (APSI): Paraphilia with androphilic or gynephilic Tanner 5 SI Marker (Sexual Incitation)

Treatment:

Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

Sham Comparator

Sham Comparator group

Description:

Medical Device Sham Comparator taVGN (Cranial Ten - Vagus Nerve) Selection of Random Participants In Any Subgroup Class Androphilic or gynephilic SI Marker (Sexual Incitation)

Treatment:

Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

T2 Subgroup

Experimental group

Description:

Two T2 Subgroups: Paraphilia with androphilic or gynephilic Tanner 2 SI Marker (Sexual Incitation)

Treatment:

Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

T4 Subgroup

Experimental group

Description:

Two T4 Subgroups: Paraphilia with androphilic or gynephilic Tanner 4 SI Marker (Sexual Incitation)

Treatment:

Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve