UnknownNot Applicable

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

100 participantsStarted 2023-09-15

Plain-language 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

Who can participate

Age range

21 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 21 to 60 years old - heterosexual identifying as he/him Exclusion Criteria: * 35 to 40 age group - heterosexual identifying as he/him

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual VITM Self-Reported Likert Scale for Desire (1 for no sexual inducement effect to 5 for intense sexual inducement effect)

Timeframe: 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))

Timeframe: 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))

Timeframe: 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))

Timeframe: Day 10 Intervention applied (atVNS) daily for 10 days followed by the VITM self-reported Likert Scale for Desire - T5 Subgroup

Trial details

NCT IDNCT05482412

SponsorAmerican University Of Montserrat

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-15

Contact for this trial

Michel R Rice, MD [AUM]

14165588601 drrice@bettercalldoc.ca

View on ClinicalTrials.gov More Desire; Sexual, Aversion trials