Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors

NCT ID: NCT06602362

Last Updated: 2025-08-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-03

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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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:

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 choking/slapping 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 cytokines/chemokines 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 (i.e., 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 (e.g., 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.

Conditions

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Sexual Behavior Hypoxia, Brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Path 1 (choking involved sex prior to non-choking involved sex)

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. 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. Subjects placed in the group following Path 1 will first come in for a baseline data collection which will occur after a 48 hour washout period of not engaging in partnered sex. Next, subjects will be asked to come in for an experimental data collection visit within the 24 hours post engaging in choking involved sex. Last, subjects will be asked to come in for an experimental data collection visit within 24 hours of engaging in sex that did not involve any choking.

Group Type EXPERIMENTAL

Partnered sex involving choking

Intervention Type OTHER

When a subject submits a survey indicating that they engaged in partnered sex involving choking, they will be asked to come in for data collection within 24 hours of survey submission.

Partnered sex not involving choking

Intervention Type OTHER

When a subject submits a survey indicating that they engaged in partnered sex that did not involve any choking, they will be asked to come in for data collection within 24 hours of survey submission.

Path 2 (non-choking involved sex prior to choking involved sex)

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. 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. Subjects placed in the group following Path 2 will first come in for a baseline data collection which will occur after a 48 hour washout period of not engaging in partnered sex. Next, subjects will be asked to come in for an experimental data collection visit within the 24 hours after engaging in sex that did not involve any choking. Last, subjects will be asked to come in for an experimental data collection visit within 24 hours of engaging in choking involved sex.

Group Type EXPERIMENTAL

Partnered sex involving choking

Intervention Type OTHER

When a subject submits a survey indicating that they engaged in partnered sex involving choking, they will be asked to come in for data collection within 24 hours of survey submission.

Partnered sex not involving choking

Intervention Type OTHER

When a subject submits a survey indicating that they engaged in partnered sex that did not involve any choking, they will be asked to come in for data collection within 24 hours of survey submission.

Interventions

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Partnered sex involving choking

When a subject submits a survey indicating that they engaged in partnered sex involving choking, they will be asked to come in for data collection within 24 hours of survey submission.

Intervention Type OTHER

Partnered sex not involving choking

When a subject submits a survey indicating that they engaged in partnered sex that did not involve any choking, they will be asked to come in for data collection within 24 hours of survey submission.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* Between the age of 18-30
* Proficient in English
* Reports engaging in sex involving being choked at least 2 times in the past month

Exclusion Criteria

* Pregnant
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Keisuke Kawata

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Indiana University School of Public Health

Bloomington, Indiana, United States

Site Status

Countries

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United States

References

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Hou J, Huibregtse ME, Alexander IL, Klemsz LM, Fu TC, Rosenberg M, Fortenberry JD, Herbenick D, Kawata K. Structural brain morphology in young adult women who have been choked/strangled during sex: A whole-brain surface morphometry study. Brain Behav. 2023 Aug;13(8):e3160. doi: 10.1002/brb3.3160. Epub 2023 Jul 17.

Reference Type BACKGROUND
PMID: 37459254 (View on PubMed)

Herbenick D, Fu TC, Eastman-Mueller H, Thomas S, Svetina Valdivia D, Rosenberg M, Guerra-Reyes L, Wright PJ, Kawata K, Feiner JR. Frequency, Method, Intensity, and Health Sequelae of Sexual Choking Among U.S. Undergraduate and Graduate Students. Arch Sex Behav. 2022 Aug;51(6):3121-3139. doi: 10.1007/s10508-022-02347-y. Epub 2022 Jul 28.

Reference Type BACKGROUND
PMID: 35902430 (View on PubMed)

Hou J, Huibregtse ME, Alexander IL, Klemsz LM, Fu TC, Fortenberry JD, Herbenick D, Kawata K. Association of Frequent Sexual Choking/Strangulation With Neurophysiological Responses: A Pilot Resting-State fMRI Study. J Neurotrauma. 2023 Jul;40(13-14):1339-1351. doi: 10.1089/neu.2022.0146. Epub 2023 Feb 28.

Reference Type BACKGROUND
PMID: 36565025 (View on PubMed)

Herbenick D, Fu TC, Patterson C, Rosenstock Gonzalez YR, Luetke M, Svetina Valdivia D, Eastman-Mueller H, Guerra-Reyes L, Rosenberg M. Prevalence and characteristics of choking/strangulation during sex: Findings from a probability survey of undergraduate students. J Am Coll Health. 2023 May-Jun;71(4):1059-1073. doi: 10.1080/07448481.2021.1920599. Epub 2021 Jul 9.

Reference Type BACKGROUND
PMID: 34242530 (View on PubMed)

Other Identifiers

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23297

Identifier Type: -

Identifier Source: org_study_id

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