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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05482412
Enrollment
100
Registered
2022-08-01
Start date
2023-09-15
Completion date
2024-12-15
Last updated
2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desire; Sexual, Aversion, Paraphilia

Keywords

Down-Regulation, Vagus Cranial Nerve Modulation, Desire Control, taVNS [transcutaneous afferent vagus nerve stimulation]

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.

Interventions

DEVICEtranscutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve

Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]

Sponsors

Greg Thomas William Consultant Research, Queens University
CollaboratorUNKNOWN
Irene Becker Consultant, Coaching Certification for Pain Management
CollaboratorUNKNOWN
Susan Jones MD PhD
CollaboratorUNKNOWN
Peter Martin BSc Forensic Psych, Masters in Education, JPH Internal Meds + Family Meds Rotation Teaching Assistant
CollaboratorUNKNOWN
Kofi McNair Nyamekye B Eng. Op. Neuromod. Masters + 4th Yr Meds Student
CollaboratorUNKNOWN
American University Of Montserrat
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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).

Intervention model description

The sequential study is involved in a translational study.

Eligibility

Sex/Gender
MALE
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroupVisual 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))Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T5 subgroupVisual stimuli (VITM Visual Inducer Testing Media Software) used to measure desire (sexual fantasy) intensity as opposed to phallometric medium

Other

MeasureTime frameDescription
Self-Reported QuestionnaireDay 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatmentQuestions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)

Contacts

Primary ContactMichel R Rice, MD [AUM]
drrice@bettercalldoc.ca14165588601

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026