Sexual BehaviorNCT06602362
Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors
A study testing Partnered sex involving choking and Partnered sex not involving choking in people with Sexual Behavior and Hypoxia, Brain, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Hypoxia, Brain
- What is being tested?
- Partnered sex involving choking and Partnered sex not involving choking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
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.
Read the 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 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
- Sexual Behavior, Hypoxia, Brain
- Being tested
- Partnered sex involving choking, Partnered sex not involving choking
- Keywords
- Sexual choking
- Medical subject headings
- Sexual Behavior, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partnered sex involving chokingOther
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 chokingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Path 1 (choking involved sex prior to non-choking involved sex) | Experimental | 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. Receives: Other: Partnered sex involving choking; Other: Partnered sex not involving choking |
| Path 2 (non-choking involved sex prior to choking involved sex) | Experimental | 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. Receives: Other: Partnered sex involving choking; Other: Partnered sex not involving choking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain-derived blood biomarkers from baseline to post choking involved sex time point
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.
Measured: Blood samples will be collected at baseline and within 24 hours after engaging in sex involving choking
Differences in brain-derived blood biomarkers between post choking involved sex time point and post non-choking involved sex time point
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.
Measured: 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
Differences in regional fMRI activation between post choking involved sex time point and post non-choking involved sex time point
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.
Measured: 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
Change in axonal microstructure from baseline to post choking involved sex time point
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.
Measured: MRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
Differences in axonal microstructure between post choking involved sex time point and post non-choking involved sex time point
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.
Measured: 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
Change in cerebral blood flow from baseline to post choking involved sex time point
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.
Measured: MRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
Difference in cerebral blood flow between post choking involved sex time point and post non-choking involved sex time point
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.
Measured: 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
Change in regional fMRI activation at rest from baseline to post choking involved sex time point
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.
Measured: fMRI procedures will be performed at baseline and within 24 hours after engaging in sex involving choking
Secondary outcomes (2)
Change in ocular-motor function from baseline to post choking involved sex time point
Participants will undergo a brief test of near-point of convergence
Measured: 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
Participants will undergo a brief test of near-point of convergence
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Oct 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keisuke Kawata, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602362
- Sponsor's protocol ID
- 23297
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data will be included in publications.
Publications
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.
PubMed 37459254Herbenick 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.
PubMed 35902430Hou 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.
PubMed 36565025Herbenick 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.
PubMed 34242530
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering the Acute Neurobiological Significance of Emerging Sexual Behaviors
- ClinicalTrials.gov ID
- NCT06602362
- Acronym / sponsor ID
- 23297
- Conditions
- Sexual Behavior, Hypoxia, Brain
- Keywords
- Sexual choking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Path 1 (choking involved sex prior to non-choking involved sex) | Experimental | Other: Partnered sex involving choking, Other: Partnered sex not involving chokingPath 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. |
| Path 2 (non-choking involved sex prior to choking involved sex) | Experimental | Other: Partnered sex involving choking, Other: Partnered sex not involving chokingPath 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partnered sex involving chokingWhen 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. | Other | Path 1 (choking involved sex prior to non-choking involved sex), Path 2 (non-choking involved sex prior to choking involved sex) |
| Partnered sex not involving chokingWhen 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. | Other | Path 1 (choking involved sex prior to non-choking involved sex), Path 2 (non-choking involved sex prior to choking involved sex) |
Primary outcome
Change in brain-derived blood biomarkers from baseline to post choking involved sex time point
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Change in ocular-motor function from baseline to post choking involved sex time point
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 37459254Hou 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.
- Background: PubMed 35902430Herbenick 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.
- Background: PubMed 36565025Hou 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.
- Background: PubMed 34242530Herbenick 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.
- Individual participant dataSharing planned: No. All study data will be included in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnered sex involving choking and Partnered sex not involving choking in people with Sexual Behavior and Hypoxia, Brain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain-derived blood biomarkers from baseline to post choking involved sex time point (time frame: Blood samples will be collected at baseline and within 24 hours after engaging in sex involving choking). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06602362, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.