NCT06602362

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

October 3, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

August 24, 2025

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

September 16, 2024

Last Update Submit

August 19, 2025

Conditions

Keywords

Sexual choking

Outcome Measures

Primary Outcomes (8)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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

    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

Study Arms (2)

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.

Other: Partnered sex involving chokingOther: 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.

Other: Partnered sex involving chokingOther: Partnered sex not involving choking

Interventions

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.

Path 1 (choking involved sex prior to non-choking involved sex)Path 2 (non-choking involved sex prior to choking involved sex)

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

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (4)

  • 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.

    PMID: 37459254BACKGROUND
  • 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.

    PMID: 35902430BACKGROUND
  • 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.

    PMID: 36565025BACKGROUND
  • 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.

    PMID: 34242530BACKGROUND

MeSH Terms

Conditions

Sexual BehaviorHypoxia, Brain

Condition Hierarchy (Ancestors)

BehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

October 3, 2024

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

August 24, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

All study data will be included in publications.

Locations