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

NCT05482412 | Unknown DMC

• 1 other identifier: PHD1002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Desire; Sexual, Aversion; Paraphilia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Other Outcomes (3)

• Self-Reported Questionnaire

  Day 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatment

• Self-Reported Questionnaire

  Day 1 Measured immediately post VITM but post taVNS treatment

• Self-Reported Questionnaire

  Day 10 - After 10 treatments within 2 weeks) Measure immediately post VITM but post taVNS treatment

Study Arms (5)

T3 Subgroup

EXPERIMENTAL

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

T5 (Young Adult) Subgroup

EXPERIMENTAL

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

Sham Comparator

SHAM COMPARATOR

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

T2 Subgroup

EXPERIMENTAL

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

T4 Subgroup

EXPERIMENTAL

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

Interventions

transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve DEVICE

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

Sham Comparator; T2 Subgroup; T3 Subgroup; T4 Subgroup; T5 (Young Adult) Subgroup

Eligibility Criteria

• Age: 21 Years - 60 Years
• Gender Eligibility Details: Male identifying as he/him heterosexual
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Related Links

• Academy North Canada Division for American University of Montserrat
• Faculty of Medicine \& University student information website

MeSH Terms

Conditions

Coitus; Paraphilic Disorders

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Mental Disorders

Study Officials

• Athavan Gananathan, MD

  CEO AUM

  STUDY DIRECTOR

Central Study Contacts

Michel R Rice, MD [AUM]

CONTACT

14165588601; drrice@bettercalldoc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Academic Dean Faculty of Medicine, Dean Research Department MD-PhD Program Faculty of Medicine

Model Details: The sequential study is involved in a translational study.

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 1, 2022
• Study Start: September 15, 2023
• Primary Completion: June 15, 2024
• Study Completion: December 15, 2024
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share