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| Name | Class |
|---|---|
| Greg Thomas William Consultant Research, Queens University | UNKNOWN |
| Irene Becker Consultant, Coaching Certification for Pain Management | UNKNOWN |
| Susan Jones MD PhD | UNKNOWN |
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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
taVNS Diagnostic Spectrum Testing Center Order of Delivery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T3 Subgroup | Experimental | Two T3 Subgroups: Paraphilia with androphilic or gynephilic Tanner 3 SI Marker (Sexual Incitation) note: incitation/stimulation |
|
| T5 (Young Adult) Subgroup | Experimental | Two T5 Subgroups Age-Play Subgroup (APSI): Paraphilia with androphilic or gynephilic Tanner 5 SI Marker (Sexual Incitation) |
|
| 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) |
|
| T2 Subgroup | Experimental | Two T2 Subgroups: Paraphilia with androphilic or gynephilic Tanner 2 SI Marker (Sexual Incitation) |
|
| T4 Subgroup | Experimental | Two T4 Subgroups: Paraphilia with androphilic or gynephilic Tanner 4 SI Marker (Sexual Incitation) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous (superficial) afferent electrical nerve stimulation specific for vagus nerve | Device | Direct superficial auricular sensory branch of Cr X [Cranial Nerve Ten Vagus] |
| 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) | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Questionnaire | 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 |
Inclusion Criteria:
Exclusion Criteria:
Male identifying as he/him heterosexual
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel R Rice, MD [AUM] | Contact | 14165588601 | drrice@bettercalldoc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Athavan Gananathan, MD | CEO AUM | Study Director |
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| Label | URL |
|---|---|
| Faculty of Medicine \& University student information website | View source |
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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.
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| 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 |
The sequential study is involved in a translational study.
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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).
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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 | 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 |
| ID | Term |
|---|---|
| D003075 | Coitus |
| D010262 | Paraphilic Disorders |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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