Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602362
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the acute effect of being choked during partnered sex on neurological measures The study is designed to identify the effects being choked during partnered sex on the brain through the use of neural-injury blood biomarkers functional diffusion and perfusion MRI and ocular-motor function across 3 time points baseline post-choking post-non-choking The central hypothesis is that acute neuronal structural physiological and functional alterations will be amplified after an incidence of choking-involved sex The neural-injury blood biomarkers neurofilament light NfL glial fibrillary acidic protein GFAP Ubiquitin C-Terminal Hydrolase L1 UCH-L1 and Tau will be measured in plasma with the hypothesis that having choking involved sex will result in a increased heightened response compared to baseline and post non-choking involved sex timepoints An additional panel of inflammatory cytokines may be considered ifwhen brain injury biomarkers show changes It is also hypothesized that engaging in choking-involved sex will be associated with changes in fMRI activation patterns White matter microstructure will be measured by diffusion imaging metrics with the hypothesis that engaging in choking-involved sex will significantly disrupt microstructure at a post-choking involved sex time point compared to baseline but not at the post non-choking involved sex timepoint The study will also assess oculomotor function as measured by near-point-of-convergence NPC in response to engaging in choking involved sex The hypothesis is that NPC performance will be significantly impaired at the post choking-involved sex timepoint in comparison to both baseline and non-choking involved sex timepoints
Detailed Description:
The researchers will use a randomized controlled trial design and recruit participants on a first-come first-serve basis for the study This will be a crossover study where subjects will experience the same research interactions and data collection methods Path 1 will involve 3 data collection time points including baseline data collection post choking involved sex data collection time point and post non-choking involved sex time point in that order Path 2 will involve 3 data collection time points including baseline data collection post non-choking involved sex time point and post choking involved sex time point in that order Each data collection timepoint will take approximately 2 hours After enrollment subjects will be sent a brief Qualtrics survey link once a day to determine when they are eligible for data collection based on their sexual activity within the last 24 hours If a subject is eligible for data collection they will come in on the following day
When written informed consent is obtained the researchers will use a self-reported health questionnaire to obtain demographic information The information includes age sex romantic relationship status sexual behavior habits number and age of previous concussions as well as assessment of other neurological conditions psychosis screening and MRI contradictions to screen participants39 eligibility Participants who meet the inclusion criteria and are free of exclusionary factors will advance to the testing procedures
Enrollment Questionnaire
The researchers will asses 1 impulsive behavior using SUPPS-P 2 Childhood trauma load using CTQ 3 lifetime trauma load using LEC5 4 ADHD symptoms using WHO ASRS for DSM-5 5 aggression in relationships using CTS2S 6 insomnia symptoms using ISI 7 migraine disability in the last 3 months using MIDAS 8 sex amp sex behavior habits 9 lifetime choking history 10 lifetime sexual smotheringslapping history 11 demographics 12 alcohol use disorder using AUDIT 13 cannabis use disorder using CUDIT 14 MRI contradictions using MRI safety screening form
Data Collection Questionnaires
The researchers will assess 1 depression anxiety perceived stress symptoms using the PHQ-9 GAD-7 and the Perceived Stress Scale 2 neurobehavioral symptoms using the Neurobehavioral Symptom Inventory 3 menstrual cycle 4 health and behaviors in the last 24 hours related to sleep head impacts caffeine intake exercise medication 5 recent masturbation 6 event level chokingslapping history
NPC
During each test session NPC assessment will be conducted on each participant Near point of convergence NPC will be used to assessed ocular-motor function The NPC measures the closest point to which one can maintain convergence while focusing on an object before double vision occurs Assessment will be repeated twice and mean NPC scores will be used for statistical analyses
Blood Biomarkers
Antecubital vein blood draws will be performed each test session to help determine serum biomarker concentrations A trained phlebotomist will thoroughly clean the inner elbow surface with an alcohol swab and draw 7 ml of whole blood into sterile Vacutainer tubes with 21G butterfly needle After the blood draw the participant will use gauze to maintain direct pressure and a bandage will be provided Plasma will be assessed by the 4-plex Simoa assay platform Quanterix which is a magnetic bead-based ELISA that allows detection of biomarkers in femtomolar concentrations Additional panels of inflammatory cytokineschemokines will be assessed by the Luminex system
MRI Techniques
Once completing the MRI screening procedure participants will undergo the following standardized MRI protocols
Diffusion tensor imaging DTI DTI is the most widely used technique to study the microstructural integrity of white matter in vivo DTI provides simple markers such as mean diffusivity MD and fractional anisotropy FA that have been used to reflect microstructural tissue change during aging neurological disorders and traumatic brain injury ie concussion However despite their sensitivity MD and FA represent cellular diffusivity estimated by basic statistical descriptions that do not directly correspond to biophysiological parameters of the neural cellular integrity DTI assumes Gaussian diffusion within a single microstructural compartment and thus has proven non-specific to axonal structural damage To address this limitation neurite orientation dispersion and density imaging NODDI has been characterized to assess microstructural integrity of axons using a non-Gaussian model with multiple compartments NODDI allows researchers to measure axonal density within white matter orientation of axonal dispersion and free water diffusion The combined approach using NODDI and DTI will uncover greater depth of progressive axonal degeneration in response to sexual choking
Perfusion ASL arterial spin labeling MRI is an emerging non-invasive technique used to measure cerebral blood flow ASL creates an image of blood flow throughout the brain by magnetically labeling blood water molecules as an intrinsic tracer while they travel to the brain ASL offers an advantage over contrast bolus techniques as it is non-invasive and does not require the use of a contrast agent Additionally ASL allows for the quantification of cerebral blood flow which offers an advantage over traditional contrast MR perfusion The use of ASL MRI will uncover potential alteration in cerebral blood flow in response to sexual choking
Resting-state fMRI Measures of functional connectivity will be computed using a seed-based correlational approach adapted for cortical surface-based analysis The dorsolateral prefrontal cortex is set as our primary seed region but all other regions eg corpus callosum angular gyrus cingulate gyrus will also be tested Pre-analysis processing surface sampling ROI averaging and motion censoring are adapted from the ABCD protocol For network analysis the investigators will calculate correlation values for each pair of ROIs which are Fisher-transformed to z-statistics and averaged within or between networks to provide summary measures of network strength The investigators will compute network metrics using the brain connectivity toolbox and compare connectivity measures within and between groups at each time point
When written informed consent is obtained the researchers will use a self-reported health questionnaire to obtain demographic information The information includes age sex romantic relationship status sexual behavior habits number and age of previous concussions as well as assessment of other neurological conditions psychosis screening and MRI contradictions to screen participants39 eligibility Participants who meet the inclusion criteria and are free of exclusionary factors will advance to the testing procedures
Enrollment Questionnaire
The researchers will asses 1 impulsive behavior using SUPPS-P 2 Childhood trauma load using CTQ 3 lifetime trauma load using LEC5 4 ADHD symptoms using WHO ASRS for DSM-5 5 aggression in relationships using CTS2S 6 insomnia symptoms using ISI 7 migraine disability in the last 3 months using MIDAS 8 sex amp sex behavior habits 9 lifetime choking history 10 lifetime sexual smotheringslapping history 11 demographics 12 alcohol use disorder using AUDIT 13 cannabis use disorder using CUDIT 14 MRI contradictions using MRI safety screening form
Data Collection Questionnaires
The researchers will assess 1 depression anxiety perceived stress symptoms using the PHQ-9 GAD-7 and the Perceived Stress Scale 2 neurobehavioral symptoms using the Neurobehavioral Symptom Inventory 3 menstrual cycle 4 health and behaviors in the last 24 hours related to sleep head impacts caffeine intake exercise medication 5 recent masturbation 6 event level chokingslapping history
NPC
During each test session NPC assessment will be conducted on each participant Near point of convergence NPC will be used to assessed ocular-motor function The NPC measures the closest point to which one can maintain convergence while focusing on an object before double vision occurs Assessment will be repeated twice and mean NPC scores will be used for statistical analyses
Blood Biomarkers
Antecubital vein blood draws will be performed each test session to help determine serum biomarker concentrations A trained phlebotomist will thoroughly clean the inner elbow surface with an alcohol swab and draw 7 ml of whole blood into sterile Vacutainer tubes with 21G butterfly needle After the blood draw the participant will use gauze to maintain direct pressure and a bandage will be provided Plasma will be assessed by the 4-plex Simoa assay platform Quanterix which is a magnetic bead-based ELISA that allows detection of biomarkers in femtomolar concentrations Additional panels of inflammatory cytokineschemokines will be assessed by the Luminex system
MRI Techniques
Once completing the MRI screening procedure participants will undergo the following standardized MRI protocols
Diffusion tensor imaging DTI DTI is the most widely used technique to study the microstructural integrity of white matter in vivo DTI provides simple markers such as mean diffusivity MD and fractional anisotropy FA that have been used to reflect microstructural tissue change during aging neurological disorders and traumatic brain injury ie concussion However despite their sensitivity MD and FA represent cellular diffusivity estimated by basic statistical descriptions that do not directly correspond to biophysiological parameters of the neural cellular integrity DTI assumes Gaussian diffusion within a single microstructural compartment and thus has proven non-specific to axonal structural damage To address this limitation neurite orientation dispersion and density imaging NODDI has been characterized to assess microstructural integrity of axons using a non-Gaussian model with multiple compartments NODDI allows researchers to measure axonal density within white matter orientation of axonal dispersion and free water diffusion The combined approach using NODDI and DTI will uncover greater depth of progressive axonal degeneration in response to sexual choking
Perfusion ASL arterial spin labeling MRI is an emerging non-invasive technique used to measure cerebral blood flow ASL creates an image of blood flow throughout the brain by magnetically labeling blood water molecules as an intrinsic tracer while they travel to the brain ASL offers an advantage over contrast bolus techniques as it is non-invasive and does not require the use of a contrast agent Additionally ASL allows for the quantification of cerebral blood flow which offers an advantage over traditional contrast MR perfusion The use of ASL MRI will uncover potential alteration in cerebral blood flow in response to sexual choking
Resting-state fMRI Measures of functional connectivity will be computed using a seed-based correlational approach adapted for cortical surface-based analysis The dorsolateral prefrontal cortex is set as our primary seed region but all other regions eg corpus callosum angular gyrus cingulate gyrus will also be tested Pre-analysis processing surface sampling ROI averaging and motion censoring are adapted from the ABCD protocol For network analysis the investigators will calculate correlation values for each pair of ROIs which are Fisher-transformed to z-statistics and averaged within or between networks to provide summary measures of network strength The investigators will compute network metrics using the brain connectivity toolbox and compare connectivity measures within and between groups at each time point
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None