Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change in brain-derived blood biomarkers from baseline to post choking involved sex time point
研究概览
简要总结
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 if/when 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.
详细描述
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 participants' 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 & sex behavior habits; (9) lifetime choking history; (10) lifetime sexual smothering/slapping 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The primary investigator will be blinded to the study participants' study group status, and the statistician will be blinded from group assignment. Additionally, participants will be blinded to their own group status.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Between the age of 18-30
- •Proficient in English
- •Reports engaging in sex involving being choked at least 2 times in the past month
排除标准
- •History of moderate to severe TBI
- •Has had a concussion in the last 6 months
- •Any MRI contraindication (metal inside body near neck, face, head; metal IUD; severe claustrophobia; etc)
- •Neurological condition (epilepsy, neurodegenerative disease, aneurysm, tumor, SCI, etc)
- •Reports experiencing psychotic symptoms as measured by the Revised Behavior and Symptom Identification Scale
- •Reports currently taking antipsychotic medication
- •Reports less than 2 instances of being choked during partnered sexual events during the past month
- •Reports engaging in sex without choking no times in the past month (i.e. reports strictly engaging in sex involving choking in the past month)
结局指标
主要结局
Change in brain-derived blood biomarkers from baseline to post choking involved sex time point
时间窗: Blood samples will be collected at baseline and within 24 hours after engaging in sex involving choking
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum samples will be aliquoted and stored at -80 degree celsius until analysis. Serum samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), tau, and Ubiquitin C- terminal Hydrolase 1 (UCH-L1). All expression levels in pg/mL.
Differences in brain-derived blood biomarkers between post choking involved sex time point and post non-choking involved sex time point
时间窗: Blood samples will be collected within 24 hours after engaging in sex involving choking and within 24 hours of engaging in non-choking involved sex
Blood samples will be collected and centrifuged at 1500 x g for ten minutes at 4 degree celsius. Serum samples will be aliquoted and stored at -80 degree celsius until analysis. Serum samples will be assayed for neurofilament-light (NfL), glial fibrillary acidic protein (GFAP), tau, and Ubiquitin C- terminal Hydrolase 1 (UCH-L1). All expression levels in pg/mL.
Differences in regional fMRI activation between post choking involved sex time point and post non-choking involved sex time point
时间窗: fMRI procedures will be performed within 24 hours after engaging in sex involving choking and within 24 hours of engaging in non-choking involved sex
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with an eight channel phased array head radiofrequency coil will be used to collect fMRI images while a risk taking task is administered. The task based fMRI protocol will consist of BART task to assess risk taking behavior and a function Resting State task.
Change in axonal microstructure from baseline to post choking involved sex time point
时间窗: MRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in diffusion metrics. Whole-brain Diffusion tensor imaging (DTI) will be performed with a multi-slice single-shot spin echo echoplanar pulse sequence (echo time \[TE\] = 81 ms; repetition time \[TR\] = 9 s) using 64 diffusion-encoding directions, isotopically distributed over the surface of a sphere with electrostatic repulsion.
Differences in axonal microstructure between post choking involved sex time point and post non-choking involved sex time point
时间窗: MRI procedures will be performed within 24 hours after engaging in sex involving choking and within 24 hours of engaging in non-choking involved sex
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in diffusion metrics. Whole-brain Diffusion tensor imaging (DTI) will be performed with a multi-slice single-shot spin echo echoplanar pulse sequence (echo time \[TE\] = 81 ms; repetition time \[TR\] = 9 s) using 64 diffusion-encoding directions, isotopically distributed over the surface of a sphere with electrostatic repulsion.
Change in cerebral blood flow from baseline to post choking involved sex time point
时间窗: MRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in perfusion metrics.
Difference in cerebral blood flow between post choking involved sex time point and post non-choking involved sex time point
时间窗: MRI procedures will be performed within 24 hours after engaging in sex involving choking and within 24 hours of engaging in non-choking involved sex
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with a 64 channel phased array head radiofrequency coil will be used to assess changes in perfusion metrics.
Change in regional fMRI activation at rest from baseline to post choking involved sex time point
时间窗: fMRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
A standardized MRI protocol acquired on a Siemens TIM Trio scanner, equipped with an eight channel phased array head radiofrequency coil will be used to collect fMRI images while at rest.
次要结局
- Change in ocular-motor function from baseline to post choking involved sex time point(Near point of convergence will be assessed at baseline and within 24 hours after engaging in sex involving choking)
- Difference in ocular-motor function between post choking involved sex time point and post non-choking involved sex time point(Near point of convergence will be assessed within 24 hours after engaging in sex involving choking and within 24 hours of engaging in non-choking involved sex)
研究者
Keisuke Kawata
Associate Professor
Indiana University