Desire; Sexual, AversionNCT05482412
Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration
A study testing transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve in people with Desire; Sexual, Aversion and Paraphilia, run by American University Of Montserrat.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Desire; Sexual, Aversion, Paraphilia
- What is being tested?
- transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21 to 60 years old - heterosexual identifying as he/him
Who cannot join
- 35 to 40 age group - heterosexual identifying as he/him
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the detailed description
taVNS Diagnostic Spectrum Testing Center Order of Delivery
- - Addiction - Opioid
- - Chronic Pain - Central
- - Anxiety + Panic Disorder
- - MDD - Major Depression Disorder
- - Addiction - Nicotine
- - ADHD
- - Addiction - Stimulant
- - Addiction - Sexual + Love
- - Addiction - Paraphilia
- - Parkinsons
- - Immune Enhancing
- - 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.
- Conditions
- Desire; Sexual, Aversion, Paraphilia
- Being tested
- transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
- Keywords
- Down-Regulation, Vagus Cranial Nerve Modulation, Desire Control, taVNS [transcutaneous afferent vagus nerve stimulation]
- Medical subject headings
- Coitus, Paraphilic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveDevice
Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus]
| Study group | Role | What they receive |
|---|---|---|
| T3 Subgroup | Experimental | Two T3 Subgroups:
Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Sep 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desire; Sexual, AversionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The sequential study is involved in a translational study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University Of Montserrat
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Dr. Michel Rice, American University Of Montserrat
- Investigators
- Athavan Gananathan, MD, Study director, CEO AUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482412
- Sponsor's protocol ID
- PHD1002
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Paraphilic Pathway Down-Regulation In A Specialized Sensitive Group Using taVNS Modulation
- ClinicalTrials.gov ID
- NCT05482412
- Acronym / sponsor ID
- PHD1002
- Conditions
- Desire; Sexual, Aversion, Paraphilia
- Keywords
- Down-Regulation, Vagus Cranial Nerve Modulation, Desire Control, taVNS [transcutaneous afferent vagus nerve stimulation]
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- American University Of MontserratUniversity, hospital or other
- 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
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- - Addiction - Opioid
- - Chronic Pain - Central
- - Anxiety + Panic Disorder
- - MDD - Major Depression Disorder
- - Addiction - Nicotine
- - ADHD
- - Addiction - Stimulant
- - Addiction - Sexual + Love
- - Addiction - Paraphilia
- - Parkinsons
- - Immune Enhancing
- - 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- The sequential study is involved in a translational study.
| Arm | Type | Receives |
|---|---|---|
| T3 Subgroup | Experimental | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveTwo T3 Subgroups: Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation |
| T5 (Young Adult) Subgroup | Experimental | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveTwo T5 Subgroups Age-Play Subgroup (APSI): Paraphilia with androphilic or gynephilic Tanner 5 SI Marker (Sexual Incitation) |
| Sham Comparator | Sham comparator | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveMedical Device Sham Comparator taVGN (Cranial Ten - Vagus Nerve) Selection of Random Participants In Any Subgroup Class Androphilic or gynephilic SI Marker (Sexual Incitation) |
| T2 Subgroup | Experimental | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveTwo T2 Subgroups: Paraphilia with androphilic or gynephilic Tanner 2 SI Marker (Sexual Incitation) |
| T4 Subgroup | Experimental | Device: transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveTwo T4 Subgroups: Paraphilia with androphilic or gynephilic Tanner 4 SI Marker (Sexual Incitation) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 21 to 60 years old - heterosexual identifying as he/him
Key exclusion criteria (1 listed)
- 35 to 40 age group - heterosexual identifying as he/him
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerveDirect superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus] | Device | Sham Comparator, T2 Subgroup, T3 Subgroup, T4 Subgroup, T5 (Young Adult) Subgroup |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Faculty of Medicine \& University student information websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athavan Gananathan, MD study director
CEO AUM
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve in people with Desire; Sexual, Aversion and Paraphilia, run by American University Of Montserrat.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michel R Rice, MD [AUM] (14165588601, drrice@bettercalldoc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.