Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration
NCT ID: NCT05482412
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2023-09-15
2024-12-15
Brief Summary
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Testing Center Order of Deliver Number
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
The taVNS intervention is also triple blinded (participant sham intervention, observer, care provider, investigators \& assessors).
Study Groups
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T3 Subgroup
Two T3 Subgroups:
Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
T5 (Young Adult) Subgroup
Two T5 Subgroups Age-Play Subgroup (APSI):
Paraphilia with androphilic or gynephilic Tanner 5 SI Marker (Sexual Incitation)
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
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)
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
T2 Subgroup
Two T2 Subgroups:
Paraphilia with androphilic or gynephilic Tanner 2 SI Marker (Sexual Incitation)
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
T4 Subgroup
Two T4 Subgroups:
Paraphilia with androphilic or gynephilic Tanner 4 SI Marker (Sexual Incitation)
transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
Interventions
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transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve
Direct superficial auricular sensory branch of Cr X \[Cranial Nerve Ten Vagus\]
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
60 Years
MALE
Yes
Sponsors
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Greg Thomas William Consultant Research, Queens University
UNKNOWN
Irene Becker Consultant, Coaching Certification for Pain Management
UNKNOWN
Susan Jones MD PhD
UNKNOWN
Peter Martin BSc Forensic Psych, Masters in Education, JPH Internal Meds + Family Meds Rotation Teaching Assistant
UNKNOWN
Kofi McNair Nyamekye B Eng. Op. Neuromod. Masters + 4th Yr Meds Student
UNKNOWN
American University Of Montserrat
OTHER
Responsible Party
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Dr. Michel Rice
Associate Academic Dean Faculty of Medicine, Dean Research Department MD-PhD Program Faculty of Medicine
Principal Investigators
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Athavan Gananathan, MD
Role: STUDY_DIRECTOR
CEO AUM
Central Contacts
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Related Links
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Academy North Canada Division for American University of Montserrat
Faculty of Medicine \& University student information website
Other Identifiers
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PHD1002
Identifier Type: -
Identifier Source: org_study_id
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