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

July 19, 2023 updated by: Dr. Michel Rice, American University Of Montserrat

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T3 Subgroup

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
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]
Experimental: T5 (Young Adult) Subgroup

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
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]
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
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]
Experimental: T2 Subgroup

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
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]
Experimental: T4 Subgroup

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

What is the study measuring?

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)
Time Frame: Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T4 subgroup
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))
Time Frame: Day 1 Intervention applied (atVNS) immediately after VITM testing if subject tested positive for desire in T5 subgroup
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))
Time Frame: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T4 Subgroup
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))
Time Frame: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Questionnaire
Time Frame: Day 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatment
Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)
Day 1 Measured immediately post VITM testing of self-reported desire levels but before taVNS treatment
Self-Reported Questionnaire
Time Frame: Day 1 Measured immediately post VITM but post taVNS treatment
Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)
Day 1 Measured immediately post VITM but post taVNS treatment
Self-Reported Questionnaire
Time Frame: Day 10 - After 10 treatments within 2 weeks) Measure immediately post VITM but post taVNS treatment
Questions specific to participants' overall levels of desire intensity and distress in Likert Scale (1 no desire and 5 intense desire)
Day 10 - After 10 treatments within 2 weeks) Measure immediately post VITM but post taVNS treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University Of Montserrat

Collaborators

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

Investigators

  • Study Director: Athavan Gananathan, MD, CEO AUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2023

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

July 19, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHD1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study investigation began in 2015 during similar systematic review paper contractual work for international medical device manufacturers.

This study involves sensitive subject matter requiring expected legal enforcements of research data collection and data/participant privacy protection.

For these reasons, the data collected in this PhD study will not be shared.

This research is owned by the University of Montserrat. VITM software is available for sharing without its sensitive materials for use by other researchers internationally. Please contact the University for more information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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