Recurrent Pregnancy Loss Without Current PregnancyNCT07045818
Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety
An observational study of Recurrent Pregnancy Loss Without Current Pregnancy and Anxiety Disorder, run by Shenyang Medical College at 4 sites in China.
Trial summary
This exploratory clinical study, NEURO-CARD-2, will use simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its association with autonomic sympathetic activation in women with recurrent… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss Without Current Pregnancy, Anxiety Disorder
- What is being tested?
- Multisensory aversive emotional challenge task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 4 sitesChina
- Study dates
- 2 Jul 2025to 25 Apr 2026
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Recruitment is expected to occur through obstetrics and gynecology outpatient clinics, as well as community outreach via flyers and media campaigns.
Who may be able to join
- Female, age 18 to 45 years, right-handed;
- Diagnosis of recurrent pregnancy loss, defined as two or more consecutive spontaneous miscarriages before 28 weeks of gestation;
- Not currently pregnant, or diagnosed with missed abortion at the time of assessment;
- Completed a structured psychiatric evaluation conducted by licensed psychiatrists at each center, with diagnostic confirmation according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- For participants assigned to the RPL with anxiety group: meets DSM-5 diagnostic criteria for generalized anxiety disorder, has a Hamilton Anxiety Rating Scale score of at least 14, and has a 17-item Hamilton Depression Rating Scale score of 17 or lower;
- For participants assigned to the RPL without anxiety group: does not meet DSM-5 diagnostic criteria for generalized anxiety disorder, has a Hamilton Anxiety Rating Scale score below 14, and has a 17-item Hamilton Depression Rating Scale score of 17 or lower.
Who cannot join
- Use of psychotropic medication within the past month, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, benzodiazepines, antipsychotics, or mood stabilizers;
- Unstable or uncontrolled blood pressure, defined as systolic blood pressure greater than 180 mmHg or less than 90 mmHg at screening;
- Major comorbid organic conditions that could affect autonomic or neural measurements, including hyperthyroidism, atrial fibrillation, clinically significant valvular heart disease, prior stroke, epilepsy, traumatic brain injury, or chronic pulmonary disease;
- Significant sensory or communication barriers that could impair task performance or stimulus perception, including hearing impairment, language difficulty, or sensory neuropathy;
- High suicide risk or severe psychiatric comorbidity, including psychotic disorders, bipolar disorder, or substance use disorders;
- Marked intolerance to auditory, visual, or cold stimuli based on medical history or pre-test report;
- Any other condition judged by the study physician to interfere with safe participation in the multisensory aversive stimulation protocol.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, 110001
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110024
157 Hospital of Liaoning Health Industry Group
Shenyang, Liaoning, 110045
242 Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110086
About this study
Official title: Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety: a Multicenter Simultaneous fNIRS-ECG Study (NEURO-CARD-fNIRS)
This exploratory clinical study, NEURO-CARD-2, will use simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its association with autonomic sympathetic activation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. Using a standardized multisensory aversive emotional stimulation paradigm, the study will assess cortical and cardiac responses within a Brain-Heart-Emotion interaction framework. The objective will be to identify neurobiological signatures of emotion-autonomic dysregulation in this population and to inform the future development of precision-targeted interventions.
Read the detailed description
For this protocol, recurrent pregnancy loss (RPL) was defined as two or more consecutive spontaneous miscarriages before 28 weeks of gestation. RPL affects approximately 2-5% of reproductive-age couples worldwide and imposes a substantial clinical and emotional burden. In addition to its reproductive consequences, RPL is associated with a substantial psychological burden, and approximately 50% of affected women experience chronic anxiety. This emotional burden has been linked to persistent sympathetic activation, including elevated resting heart rate and reduced heart rate variability, which may contribute to cardiovascular and reproductive risk.
Contemporary psycho-cardiology models, including statements from the American Heart Association, emphasize the close relationship between emotional dysregulation and autonomic dysfunction. The neural mechanisms linking altered central emotion regulation to cardiac autonomic outcomes in women with RPL remain insufficiently characterized, particularly in those with comorbid anxiety.
Emerging work in interoceptive neuroscience suggests that higher-order brain regions may provide shared neural substrates for anxiety and sympathetic overactivation. The dorsolateral prefrontal cortex (DLPFC), a key node in the cognitive control network and central autonomic network, is of particular interest. Neuroimaging and neuromodulation studies have shown hemispheric asymmetry within the DLPFC. The right DLPFC has been associated with threat processing, anxiety, and sympathetic arousal, whereas the left DLPFC has been associated with cognitive reappraisal, emotional inhibition, and parasympathetic modulation.
A Brain-Heart-Emotion interaction model underlies this study. Within this framework, effective autonomic adaptation during negative emotional challenge is hypothesized to depend on coordinated bilateral DLPFC recruitment. Functional decoupling, expressed as right-lateralized DLPFC dominance, may weaken emotion regulation capacity and promote sympathetic overactivation. In women with RPL and comorbid anxiety, this pattern is hypothesized to contribute to the convergence of emotional dysregulation and cardiac dysfunction, with potential implications for reproductive and cardiovascular risk.
To evaluate this hypothesis, this prospective exploratory clinical study will use simultaneous fNIRS and ECG during a standardized multisensory emotional provocation paradigm. Patterns of interhemispheric DLPFC activation and their associations with heart rate dynamics will be examined in women with RPL with and without comorbid anxiety within the proposed Brain-Heart-Emotion framework.
If confirmed, the findings may provide mechanistic insight and empirical support for neurobiologically informed precision-targeted interventions. Potential implications may include support for inhibitory neuromodulation targeting the right DLPFC, with possible benefits for emotional regulation, autonomic balance, long-term cardiovascular risk reduction, and reproductive outcomes in this high-risk population.
- Being tested
- Multisensory aversive emotional challenge task
- Keywords
- recurrent pregnancy loss, anxiety, emotion-autonomic dysregulation, dorsolateral prefrontal cortex, functional near-infrared spectroscopy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisensory aversive emotional challenge taskBehavioural
Participants will undergo a standardized multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. The protocol will use a block design with 12 stimulation blocks, each comprising a 20 s resting phase followed by a 30 s multisensory stimulation phase. During stimulation, participants will view six negative high-arousal images per block selected from the Geneva Affective Picture Database, while concurrently being exposed to time-locked band-limited white noise calibrated to approximately 90 dB(A) and placing both hands on a 0.5 liter bottle filled with ice water maintained at approximately 0 °C. The auditory stimulus will have spectral energy restricted to 2-6 kHz. This standardized multisensory protocol will be used to elicit negative affect and sympathetic arousal.
| Study group | Role | What they receive |
|---|---|---|
| Women with recurrent pregnancy loss and comorbid anxiety | Women with recurrent pregnancy loss who will meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will be compared with women with recurrent pregnancy loss without comorbid anxiety to evaluate DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features. Receives: Behavioral: Multisensory aversive emotional challenge task | |
| Women with recurrent pregnancy loss without comorbid anxiety | Women with recurrent pregnancy loss who will not meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will serve as the comparison group for evaluating DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features. Receives: Behavioral: Multisensory aversive emotional challenge task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group-dependent hemispheric asymmetry of DLPFC activation during aversive emotional stimulation (group × hemisphere interaction)
The primary endpoint will be the group-by-hemisphere interaction in task-evoked DLPFC HbO activation during aversive emotional stimulation, comparing women with recurrent pregnancy loss (RPL) with anxiety versus without anxiety. Hemisphere will be defined as right versus left DLPFC, measured within the same participant. The participant-level activation metric will be the DLPFC HbO response estimate (β) derived from the prespecified fNIRS analysis pipeline. The primary hypothesis will be tested using a linear mixed-effects model (LME) fitted by restricted maximum likelihood, with prespecified covariates including age, education, body mass index, miscarriage etiology category, and resting heart rate. The primary confirmatory test will evaluate whether the right-minus-left difference in DLPFC activation differs by group.
Measured: Single-session fNIRS-ECG protocol (Day 1)
Secondary outcomes (2)
Group difference in interhemispheric synchronization of DLPFC activity
Interhemispheric DLPFC synchronization will be assessed using wavelet transform coherence (WTC) between homologous left and right DLPFC HbO signals. For each participant, coherence values will be averaged across the task-relevant low-frequency band (0.01-0.08 Hz) and across the stimulation period, background-corrected using the 3-minute resting period, and Fisher z-transformed to yield a participant-level synchronization metric. Between-group differences will be summarized descriptively and tested using a two-sample independent t test and a covariate-adjusted linear regression model with prespecified covariates. Prespecified supporting analyses will repeat the same computation and inferential framework across four additional prefrontal subregions to assess spatial specificity.
Measured: Single-session fNIRS-ECG protocol (Day 1)
Group difference in mean heart-rate increase during aversive emotional stimulation
Autonomic reactivity will be assessed as the mean heart-rate increase during aversive stimulation relative to the resting baseline, derived from ECG over the prespecified task window using a uniform preprocessing pipeline across participants. Preprocessed R-R intervals will be resampled at 11 Hz, filtered with a fourth-order low-pass Butterworth filter with a 0.1 Hz cutoff, detrended, segmented into 40-second epochs consisting of 10 seconds before stimulus onset and 30 seconds during stimulation, and baseline-corrected using the 10-second prestimulus period. The resulting heart-rate increase will be averaged across the 12 blocks for each participant. Between-group differences will be tested using a two-sample independent t test and a covariate-adjusted linear regression model.
Measured: Single-session fNIRS-ECG protocol (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start2 Jul 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss Without Current PregnancyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Tao, Shenyang Medical College
- Investigators
- Yun-En Liu, MD, Study chair, Shenyang Medical CollegeLin Tao, MM, Principal investigator, Shenyang Medical CollegeFei Meng, MD, Study director, Central Hospital Affiliated to Shenyang Medical CollageXiu-Ling Zhang, MD, Study director, The Second Hospital of Shenyang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045818
- Sponsor's protocol ID
- NEURO-CARD-fNIRS_Version3
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-dentified individual participant data, together with the full study protocol, MATLAB analysis scripts, and all supporting materials, will be released in full at the time of publication of the final manuscript. All materials will be deposited on one internationally recognized open science repository selected by the research team, such as Open Science Framework (https://osf.io), Zenodo (https://zenodo.org), or GitHub (https://github.com). Access will be granted for non-commercial research purposes. Requests for additional information may be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Interhemispheric DLPFC Coordination and Cardiac Hyperreactivity During Multisensory Aversive Challenge in Recurrent Pregnancy Loss With Comorbid Anxiety: a Multicenter Simultaneous fNIRS-ECG Study (NEURO-CARD-fNIRS)
- ClinicalTrials.gov ID
- NCT07045818
- Acronym / sponsor ID
- NEURO-CARD-fNIRS_Version3
- Keywords
- recurrent pregnancy loss, anxiety, emotion-autonomic dysregulation, dorsolateral prefrontal cortex, functional near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shenyang Medical CollegeUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 25 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 1 Jul 2025 (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.
This exploratory clinical study, NEURO-CARD-2, will use simultaneous functional near-infrared spectroscopy (fNIRS) and electrocardiography (ECG) to investigate interhemispheric dysfunction in the dorsolateral prefrontal cortex (DLPFC) and its association with autonomic sympathetic activation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. Using a standardized multisensory aversive emotional stimulation paradigm, the study will assess cortical and cardiac responses within a Brain-Heart-Emotion interaction framework. The objective will be to identify neurobiological signatures of emotion-autonomic dysregulation in this population and to inform the future development of precision-targeted interventions.
Detailed description
For this protocol, recurrent pregnancy loss (RPL) was defined as two or more consecutive spontaneous miscarriages before 28 weeks of gestation. RPL affects approximately 2-5% of reproductive-age couples worldwide and imposes a substantial clinical and emotional burden. In addition to its reproductive consequences, RPL is associated with a substantial psychological burden, and approximately 50% of affected women experience chronic anxiety. This emotional burden has been linked to persistent sympathetic activation, including elevated resting heart rate and reduced heart rate variability, which may contribute to cardiovascular and reproductive risk.
Contemporary psycho-cardiology models, including statements from the American Heart Association, emphasize the close relationship between emotional dysregulation and autonomic dysfunction. The neural mechanisms linking altered central emotion regulation to cardiac autonomic outcomes in women with RPL remain insufficiently characterized, particularly in those with comorbid anxiety.
Emerging work in interoceptive neuroscience suggests that higher-order brain regions may provide shared neural substrates for anxiety and sympathetic overactivation. The dorsolateral prefrontal cortex (DLPFC), a key node in the cognitive control network and central autonomic network, is of particular interest. Neuroimaging and neuromodulation studies have shown hemispheric asymmetry within the DLPFC. The right DLPFC has been associated with threat processing, anxiety, and sympathetic arousal, whereas the left DLPFC has been associated with cognitive reappraisal, emotional inhibition, and parasympathetic modulation.
A Brain-Heart-Emotion interaction model underlies this study. Within this framework, effective autonomic adaptation during negative emotional challenge is hypothesized to depend on coordinated bilateral DLPFC recruitment. Functional decoupling, expressed as right-lateralized DLPFC dominance, may weaken emotion regulation capacity and promote sympathetic overactivation. In women with RPL and comorbid anxiety, this pattern is hypothesized to contribute to the convergence of emotional dysregulation and cardiac dysfunction, with potential implications for reproductive and cardiovascular risk.
To evaluate this hypothesis, this prospective exploratory clinical study will use simultaneous fNIRS and ECG during a standardized multisensory emotional provocation paradigm. Patterns of interhemispheric DLPFC activation and their associations with heart rate dynamics will be examined in women with RPL with and without comorbid anxiety within the proposed Brain-Heart-Emotion framework.
If confirmed, the findings may provide mechanistic insight and empirical support for neurobiologically informed precision-targeted interventions. Potential implications may include support for inhibitory neuromodulation targeting the right DLPFC, with possible benefits for emotional regulation, autonomic balance, long-term cardiovascular risk reduction, and reproductive outcomes in this high-risk population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with recurrent pregnancy loss and comorbid anxiety | – | Behavioral: Multisensory aversive emotional challenge taskWomen with recurrent pregnancy loss who will meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will be compared with women with recurrent pregnancy loss without comorbid anxiety to evaluate DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features. |
| Women with recurrent pregnancy loss without comorbid anxiety | – | Behavioral: Multisensory aversive emotional challenge taskWomen with recurrent pregnancy loss who will not meet DSM-5 criteria for a comorbid anxiety disorder. Participants in this cohort will undergo the same protocol-assigned multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. This cohort will serve as the comparison group for evaluating DLPFC activation, interhemispheric coherence, heart-rate responses, and brain-heart coupling features. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Recruitment is expected to occur through obstetrics and gynecology outpatient clinics, as well as community outreach via flyers and media campaigns.
Key inclusion criteria (6 listed)
- Female, age 18 to 45 years, right-handed;
- Diagnosis of recurrent pregnancy loss, defined as two or more consecutive spontaneous miscarriages before 28 weeks of gestation;
- Not currently pregnant, or diagnosed with missed abortion at the time of assessment;
- Completed a structured psychiatric evaluation conducted by licensed psychiatrists at each center, with diagnostic confirmation according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- For participants assigned to the RPL with anxiety group: meets DSM-5 diagnostic criteria for generalized anxiety disorder, has a Hamilton Anxiety Rating Scale score of at least 14, and has a 17-item Hamilton Depression Rating Scale score of 17 or lower;
Key exclusion criteria (7 listed)
- Use of psychotropic medication within the past month, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, benzodiazepines, antipsychotics, or mood stabilizers;
- Unstable or uncontrolled blood pressure, defined as systolic blood pressure greater than 180 mmHg or less than 90 mmHg at screening;
- Major comorbid organic conditions that could affect autonomic or neural measurements, including hyperthyroidism, atrial fibrillation, clinically significant valvular heart disease, prior stroke, epilepsy, traumatic brain injury, or chronic pulmonary disease;
- Significant sensory or communication barriers that could impair task performance or stimulus perception, including hearing impairment, language difficulty, or sensory neuropathy;
- High suicide risk or severe psychiatric comorbidity, including psychotic disorders, bipolar disorder, or substance use disorders;
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 |
|---|---|---|
| Multisensory aversive emotional challenge taskParticipants will undergo a standardized multisensory aversive stimulation paradigm during simultaneous fNIRS and ECG recording. The protocol will use a block design with 12 stimulation blocks, each comprising a 20 s resting phase followed by a 30 s multisensory stimulation phase. During stimulation, participants will view six negative high-arousal images per block selected from the Geneva Affective Picture Database, while concurrently being exposed to time-locked band-limited white noise calibrated to approximately 90 dB(A) and placing both hands on a 0.5 liter bottle filled with ice water maintained at approximately 0 °C. The auditory stimulus will have spectral energy restricted to 2-6 kHz. This standardized multisensory protocol will be used to elicit negative affect and sympathetic arousal. | Behavioural | Women with recurrent pregnancy loss and comorbid anxiety, Women with recurrent pregnancy loss without comorbid anxiety |
Primary outcome
Group-dependent hemispheric asymmetry of DLPFC activation during aversive emotional stimulation (group × hemisphere interaction)
Time frame: Single-session fNIRS-ECG protocol (Day 1)
The primary endpoint will be the group-by-hemisphere interaction in task-evoked DLPFC HbO activation during aversive emotional stimulation, comparing women with recurrent pregnancy loss (RPL) with anxiety versus without anxiety. Hemisphere will be defined as right versus left DLPFC, measured within the same participant. The participant-level activation metric will be the DLPFC HbO response estimate (β) derived from the prespecified fNIRS analysis pipeline. The primary hypothesis will be tested using a linear mixed-effects model (LME) fitted by restricted maximum likelihood, with prespecified covariates including age, education, body mass index, miscarriage etiology category, and resting heart rate. The primary confirmatory test will evaluate whether the right-minus-left difference in DLPFC activation differs by group.
2 secondary outcomes
Group difference in interhemispheric synchronization of DLPFC activity
Time frame: Single-session fNIRS-ECG protocol (Day 1)
Group difference in mean heart-rate increase during aversive emotional stimulation
Time frame: Single-session fNIRS-ECG protocol (Day 1)
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 18 Aug 2026.
- Individual participant dataSharing planned: Yes. De-dentified individual participant data, together with the full study protocol, MATLAB analysis scripts, and all supporting materials, will be released in full at the time of publication of the final manuscript. All materials will be deposited on one internationally recognized open science repository selected by the research team, such as Open Science Framework (https://osf.io), Zenodo (https://zenodo.org), or GitHub (https://github.com). Access will be granted for non-commercial research purposes. Requests for additional information may be directed to the corresponding author.
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.
Yun-En Liu, MD study chair
Shenyang Medical College
Lin Tao, MM principal investigator
Shenyang Medical College
Fei Meng, MD study director
Central Hospital Affiliated to Shenyang Medical Collage
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Pregnancy Loss Without Current Pregnancy and Anxiety Disorder, run by Shenyang Medical College at 4 sites in China.
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 6 inclusion and 7 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Group-dependent hemispheric asymmetry of DLPFC activation during aversive emotional stimulation (group × hemisphere interaction) (time frame: Single-session fNIRS-ECG protocol (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.