Recurrent Pregnancy LossNEURO-CARD-BMINCT07561931
Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI
A study testing Real repetitive transcranial magnetic stimulation in people with Recurrent Pregnancy Loss and Overweight , Obesity, run by Shenyang Medical College at 1 site in China.
Trial summary
This randomized, sham-controlled mechanistic trial will examine whether a single session of high-frequency repetitive transcranial magnetic stimulation, rTMS, applied to the left dorsolateral prefrontal cortex can modify heart-brain coupling in women with recurrent pregnancy loss and elevated body mass index, BMI. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Overweight , Obesity, Heart-Brain Coupling
- What is being tested?
- Real repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 1.Female participants aged 18-45 years and right-handed.
- 2.Fulfillment of the prespecified definition of recurrent pregnancy loss in this study, defined as at least two consecutive spontaneous miscarriages occurring before 28 weeks of gestation.
- 3.BMI ≥24 kg/m², classified as overweight or obesity according to the Chinese adult criteria for overweight and obesity.
- 4.Currently not pregnant and in a clinically stable condition. If there is a recent history of missed abortion, appropriate management must have been completed and obstetric assessment must confirm the absence of acute vaginal bleeding, infection, marked abdominal pain, or hemodynamic instability.
- 5.Ability to understand the study procedures, provide written informed consent, and cooperate with scale assessment, transcranial magnetic stimulation safety screening, and the single-session rTMS-ECG protocol.
Who cannot join
- 1.Presence of contraindications to transcranial magnetic stimulation or elevated seizure risk, including but not limited to epilepsy or a history of unexplained seizures, intracranial ferromagnetic metal implantation, or the presence of electronic or metallic implanted devices within 30 cm of the coil that are judged unsuitable for transcranial magnetic stimulation.
- 2.Current pregnancy.
- 3.Hemodynamic instability or cardiovascular abnormalities that may substantially affect interpretation of the primary endpoint, including systolic blood pressure >180 mmHg or <90 mmHg, atrial fibrillation or other clinically significant arrhythmias, valvular heart disease, marked sinus bradycardia, symptomatic coronary artery disease, or other cardiovascular conditions judged by the research team to make participation unsuitable.
- 4.Uncontrolled major medical or neurologic disorders, particularly those that may substantially affect autonomic state, ECG recording, or interpretation of the primary endpoint, including uncontrolled thyroid dysfunction, uncontrolled diabetes mellitus, significant cerebrovascular disease, neurologic disorders, or active pulmonary disease.
- 5.Presence of significant suicide risk.
- 6.Severe psychiatric disorders that may affect study safety or adherence, including schizophrenia spectrum disorders, bipolar disorder during a manic or hypomanic episode, delirium, and active substance use disorder.
Show all 9Show fewer
- 7.Severe anxiety or severe depression, defined as a Hamilton Anxiety Rating Scale total score of ≥25 or a 17-item Hamilton Depression Rating Scale total score of ≥24.
- 8.Recent medication-related confounding risk, including current withdrawal from alcohol, sedative-hypnotics, or other relevant substances, or initiation, discontinuation, or dose adjustment within the preceding 2 weeks of medications that may substantially affect seizure threshold, autonomic function, ECG-related indices, or interpretation of the primary endpoint.
- 9.Any other condition judged by the research team to make participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110024
Fei Meng, MD, 86-024-85715635, mengfei665@sohu.com
About this study
Official title: Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-BMI)
This randomized, sham-controlled mechanistic trial will examine whether a single session of high-frequency repetitive transcranial magnetic stimulation, rTMS, applied to the left dorsolateral prefrontal cortex can modify heart-brain coupling in women with recurrent pregnancy loss and elevated body mass index, BMI. Women with recurrent pregnancy loss often experience reproductive, metabolic, and emotional stress at the same time, and this combined vulnerability may be associated with altered autonomic regulation and exaggerated cardiac responses to stress. The left dorsolateral prefrontal cortex is a key brain region involved in cognitive control, emotion regulation, and top-down modulation of autonomic function.
Eligible participants will be randomly assigned in a 1:1 ratio to receive either real or sham rTMS at the same left dorsolateral prefrontal target. The stimulation protocol will use 10 Hz rTMS at 100% motor threshold, delivered in 30 cycles of 5 s stimulation followed by 11 s inter-train interval, with simultaneous 3-lead electrocardiography recording. The primary endpoint will be the between-group difference in mean heart-brain coupling across 30 stimulation cycles. Safety and tolerability will also be monitored. This study is intended to provide mechanistic evidence and methodological support for future multi-session randomized trials in this population.
Read the detailed description
Recurrent pregnancy loss is increasingly recognized not only as a reproductive disorder but also as a condition associated with broader systemic vulnerability. In women with elevated BMI, recurrent pregnancy loss may reflect a composite phenotype characterized by reproductive burden, metabolic stress, emotional distress, and altered autonomic regulation. These converging factors may contribute to exaggerated cardiac responses to stress and early cardiovascular vulnerability. The present study is based on the hypothesis that the left dorsolateral prefrontal cortex, DLPFC, is an important cortical target for top-down modulation of autonomic and heart-brain processes in this population.
This study is designed as a randomized, sham-controlled, single-session mechanistic clinical trial. Sixty women with recurrent pregnancy loss and BMI ≥24 kg/m² will be enrolled and randomly assigned in a 1:1 ratio to real-rTMS or sham-rTMS. Both groups will be stimulated over the same left DLPFC target identified using the adjusted BeamF3 method. In the sham condition, the coil will be positioned over the same target but angled at approximately 45° relative to the scalp to markedly reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Participants and outcome assessors will remain blinded to group assignment; only the operator delivering stimulation will know the assignment on the study day.
The stimulation protocol will use high-frequency rTMS at 10 Hz and 100% motor threshold. Stimulation will be delivered in 30 cycles, each consisting of a 5 s train and an 11 s inter-train interval, for a total of 1,500 pulses over approximately 8 min. During the rTMS-ECG protocol, continuous 3-lead electrocardiography will be recorded at a sampling rate of 1,000 Hz. After preprocessing, heart-brain coupling, HBC, will be quantified from cycle-locked cardiac oscillatory power at the target frequency. HBC is defined in this study as the time-averaged normalized power within the 0.062-0.063 Hz band during each 16 s stimulation cycle. The primary endpoint will be the between-group difference in mean HBC across 30 stimulation cycles, calculated with the Morlet wavelet using the default wavenumber of 6. Secondary endpoints will include mean HBC across 30 cycles under higher-frequency-resolution and higher-temporal-resolution Morlet conditions. Exploratory analyses will include repeated HBC extraction using DoG and Paul wavelets, as well as a group × stimulation progression analysis based on three sequential stages: cycles 1-10, 11-20, and 21-30.
Baseline assessments will include demographic characteristics, reproductive and medical history, comorbidities, medication use, psychiatric ratings, resting heart rate, blood pressure, and 12-lead ECG. Safety monitoring will cover common rTMS-related adverse events, including pain at the stimulation site, facial muscle contraction, mild headache, and dizziness, as well as serious adverse events such as syncope and seizure. After completion of the protocol, participants will remain under observation for 1 h, with reassessment of blood pressure and resting heart rate when clinically indicated. This trial is intended to establish a mechanistic framework for left DLPFC rTMS modulation of heart-brain coupling in women with recurrent pregnancy loss and elevated BMI and to inform the design of future multi-session randomized controlled studies.
- Being tested
- Real repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- recurrent pregnancy loss, elevated BMI, overweight, heart-brain coupling, repetitive transcranial magnetic stimulation, left dorsolateral prefrontal cortex, autonomic regulation
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real repetitive transcranial magnetic stimulationDevice
Also called real rTMS
Real rTMS will be delivered to the left dorsolateral prefrontal cortex using the adjusted BeamF3 target. The protocol will consist of 10 Hz stimulation at 100% motor threshold, delivered in 30 cycles, with each cycle including a 5 s train and an 11 s inter-train interval. The total number of pulses will be 1,500. Continuous 3-lead ECG will be recorded during stimulation.
Sham repetitive transcranial magnetic stimulationDevice
Also called sham rTMS
Sham rTMS will be delivered at the same left dorsolateral prefrontal cortex target as the real-rTMS condition. The coil will be positioned at approximately 45° relative to the scalp to reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Continuous 3-lead ECG will be recorded during the sham protocol.
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS | Experimental | Participants assigned to this arm will receive a single session of real high-frequency rTMS targeting the left dorsolateral prefrontal cortex. Stimulation will be delivered at 10 Hz and 100% motor threshold, with 30 stimulation cycles. Each cycle will include a 5 s train followed by an 11 s inter-train interval. Continuous 3-lead ECG will be recorded during the rTMS-ECG protocol. Receives: Device: Real repetitive transcranial magnetic stimulation |
| Sham rTMS | Sham comparator | Participants assigned to this arm will receive a single session of sham rTMS at the same left dorsolateral prefrontal cortex target. The coil will be angled approximately 45° relative to the scalp to markedly reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Continuous 3-lead ECG will be recorded during the rTMS-ECG protocol. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the between-group difference in mean HBC across 30 stimulation cycles.
Heart-brain coupling, HBC, is defined as the power of RR-interval or heart-rate oscillations induced by repeated TMS and locked to the stimulation-cycle frequency at the target frequency, and is used to quantify rhythmic entrainment effects. In this study, HBC is specifically defined as the time-averaged normalized power within the 0.062-0.063 Hz band during each 16 s stimulation cycle. The primary endpoint will be calculated using the Morlet wavelet, with the wavenumber set to the default value of 6 in order to achieve a relative balance between temporal resolution and frequency resolution. For each participant, 30 cycle-specific HBC values will first be obtained, and these 30 values will then be averaged to derive the participant-level mean HBC; this mean will be entered into the between-group comparison as the primary endpoint.
Measured: Day 1
Secondary outcomes (4)
Mean HBC across 30 stimulation cycles under the higher-frequency-resolution condition.
Under otherwise identical preprocessing and computational procedures, the Morlet wavelet will be used with an increased wavenumber to improve frequency resolution; cycle-specific HBC values will then be recalculated and averaged across 30 cycles to obtain the participant-level mean HBC.
Measured: Day 1
Mean HBC across 30 stimulation cycles under the higher-temporal-resolution condition.
2.Under otherwise identical preprocessing and computational procedures, the Morlet wavelet will be used with a decreased wavenumber to improve temporal resolution; cycle-specific HBC values will then be recalculated and averaged across 30 cycles to obtain the participant-level mean HBC.
Measured: Day 1
Repeated analysis using the DoG wavelet.
Under the same preprocessing and frequency-band settings as those used for the primary endpoint, the Morlet wavelet will be replaced by the DoG wavelet and the HBC extraction procedure will be repeated to examine the robustness of the findings to the choice of mother wavelet. Because the DoG wavelet is a real-valued wavelet and is more sensitive to local non-oscillatory waveform changes, its results will be used only for exploratory analysis and not as the primary basis for inference.
Measured: Day 1
Repeated analysis using the Paul wavelet.
Under the same preprocessing and frequency-band settings as those used for the primary endpoint, the Morlet wavelet will be replaced by the Paul wavelet and the HBC extraction procedure will be repeated to examine the robustness of the findings to the choice of mother wavelet. Because the Paul wavelet has relatively good temporal localization but generally weaker frequency resolution than the Morlet wavelet in the low-frequency range, its results will also be used only for exploratory analysis.
Measured: 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 May 2026
- Study start28 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: real rTMS or sham rTMS. Both groups will undergo a single-session rTMS-ECG protocol targeting the left dorsolateral prefrontal cortex. The real-rTMS group will receive high-frequency 10 Hz stimulation at 100% motor threshold. The sham-rTMS group will receive stimulation at the same scalp target with the coil angled approximately 45° relative to the scalp to reduce effective cortical stimulation while preserving acoustic and partial scalp sensory cues.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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 Collage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561931
- Sponsor's protocol ID
- 2026-024-02
- Acronym
- NEURO-CARD-BMI
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-BMI)
- ClinicalTrials.gov ID
- NCT07561931
- Acronym / sponsor ID
- NEURO-CARD-BMI / 2026-024-02
- Keywords
- recurrent pregnancy loss, elevated BMI, overweight, heart-brain coupling, repetitive transcranial magnetic stimulation, left dorsolateral prefrontal cortex, autonomic regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenyang Medical CollegeUniversity, hospital or other
- Study start
- 28 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 May 2026 (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 randomized, sham-controlled mechanistic trial will examine whether a single session of high-frequency repetitive transcranial magnetic stimulation, rTMS, applied to the left dorsolateral prefrontal cortex can modify heart-brain coupling in women with recurrent pregnancy loss and elevated body mass index, BMI. Women with recurrent pregnancy loss often experience reproductive, metabolic, and emotional stress at the same time, and this combined vulnerability may be associated with altered autonomic regulation and exaggerated cardiac responses to stress. The left dorsolateral prefrontal cortex is a key brain region involved in cognitive control, emotion regulation, and top-down modulation of autonomic function.
Eligible participants will be randomly assigned in a 1:1 ratio to receive either real or sham rTMS at the same left dorsolateral prefrontal target. The stimulation protocol will use 10 Hz rTMS at 100% motor threshold, delivered in 30 cycles of 5 s stimulation followed by 11 s inter-train interval, with simultaneous 3-lead electrocardiography recording. The primary endpoint will be the between-group difference in mean heart-brain coupling across 30 stimulation cycles. Safety and tolerability will also be monitored. This study is intended to provide mechanistic evidence and methodological support for future multi-session randomized trials in this population.
Detailed description
Recurrent pregnancy loss is increasingly recognized not only as a reproductive disorder but also as a condition associated with broader systemic vulnerability. In women with elevated BMI, recurrent pregnancy loss may reflect a composite phenotype characterized by reproductive burden, metabolic stress, emotional distress, and altered autonomic regulation. These converging factors may contribute to exaggerated cardiac responses to stress and early cardiovascular vulnerability. The present study is based on the hypothesis that the left dorsolateral prefrontal cortex, DLPFC, is an important cortical target for top-down modulation of autonomic and heart-brain processes in this population.
This study is designed as a randomized, sham-controlled, single-session mechanistic clinical trial. Sixty women with recurrent pregnancy loss and BMI ≥24 kg/m² will be enrolled and randomly assigned in a 1:1 ratio to real-rTMS or sham-rTMS. Both groups will be stimulated over the same left DLPFC target identified using the adjusted BeamF3 method. In the sham condition, the coil will be positioned over the same target but angled at approximately 45° relative to the scalp to markedly reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Participants and outcome assessors will remain blinded to group assignment; only the operator delivering stimulation will know the assignment on the study day.
The stimulation protocol will use high-frequency rTMS at 10 Hz and 100% motor threshold. Stimulation will be delivered in 30 cycles, each consisting of a 5 s train and an 11 s inter-train interval, for a total of 1,500 pulses over approximately 8 min. During the rTMS-ECG protocol, continuous 3-lead electrocardiography will be recorded at a sampling rate of 1,000 Hz. After preprocessing, heart-brain coupling, HBC, will be quantified from cycle-locked cardiac oscillatory power at the target frequency. HBC is defined in this study as the time-averaged normalized power within the 0.062-0.063 Hz band during each 16 s stimulation cycle. The primary endpoint will be the between-group difference in mean HBC across 30 stimulation cycles, calculated with the Morlet wavelet using the default wavenumber of 6. Secondary endpoints will include mean HBC across 30 cycles under higher-frequency-resolution and higher-temporal-resolution Morlet conditions. Exploratory analyses will include repeated HBC extraction using DoG and Paul wavelets, as well as a group × stimulation progression analysis based on three sequential stages: cycles 1-10, 11-20, and 21-30.
Baseline assessments will include demographic characteristics, reproductive and medical history, comorbidities, medication use, psychiatric ratings, resting heart rate, blood pressure, and 12-lead ECG. Safety monitoring will cover common rTMS-related adverse events, including pain at the stimulation site, facial muscle contraction, mild headache, and dizziness, as well as serious adverse events such as syncope and seizure. After completion of the protocol, participants will remain under observation for 1 h, with reassessment of blood pressure and resting heart rate when clinically indicated. This trial is intended to establish a mechanistic framework for left DLPFC rTMS modulation of heart-brain coupling in women with recurrent pregnancy loss and elevated BMI and to inform the design of future multi-session randomized controlled studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: real rTMS or sham rTMS. Both groups will undergo a single-session rTMS-ECG protocol targeting the left dorsolateral prefrontal cortex. The real-rTMS group will receive high-frequency 10 Hz stimulation at 100% motor threshold. The sham-rTMS group will receive stimulation at the same scalp target with the coil angled approximately 45° relative to the scalp to reduce effective cortical stimulation while preserving acoustic and partial scalp sensory cues.
| Arm | Type | Receives |
|---|---|---|
| Real rTMS | Experimental | Device: Real repetitive transcranial magnetic stimulationParticipants assigned to this arm will receive a single session of real high-frequency rTMS targeting the left dorsolateral prefrontal cortex. Stimulation will be delivered at 10 Hz and 100% motor threshold, with 30 stimulation cycles. Each cycle will include a 5 s train followed by an 11 s inter-train interval. Continuous 3-lead ECG will be recorded during the rTMS-ECG protocol. |
| Sham rTMS | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationParticipants assigned to this arm will receive a single session of sham rTMS at the same left dorsolateral prefrontal cortex target. The coil will be angled approximately 45° relative to the scalp to markedly reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Continuous 3-lead ECG will be recorded during the rTMS-ECG protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1.Female participants aged 18-45 years and right-handed.
- 2.Fulfillment of the prespecified definition of recurrent pregnancy loss in this study, defined as at least two consecutive spontaneous miscarriages occurring before 28 weeks of gestation.
- 3.BMI ≥24 kg/m², classified as overweight or obesity according to the Chinese adult criteria for overweight and obesity.
- 4.Currently not pregnant and in a clinically stable condition. If there is a recent history of missed abortion, appropriate management must have been completed and obstetric assessment must confirm the absence of acute vaginal bleeding, infection, marked abdominal pain, or hemodynamic instability.
- 5.Ability to understand the study procedures, provide written informed consent, and cooperate with scale assessment, transcranial magnetic stimulation safety screening, and the single-session rTMS-ECG protocol.
Key exclusion criteria (9 listed)
- 1.Presence of contraindications to transcranial magnetic stimulation or elevated seizure risk, including but not limited to epilepsy or a history of unexplained seizures, intracranial ferromagnetic metal implantation, or the presence of electronic or metallic implanted devices within 30 cm of the coil that are judged unsuitable for transcranial magnetic stimulation.
- 2.Current pregnancy.
- 3.Hemodynamic instability or cardiovascular abnormalities that may substantially affect interpretation of the primary endpoint, including systolic blood pressure >180 mmHg or <90 mmHg, atrial fibrillation or other clinically significant arrhythmias, valvular heart disease, marked sinus bradycardia, symptomatic coronary artery disease, or other cardiovascular conditions judged by the research team to make participation unsuitable.
- 4.Uncontrolled major medical or neurologic disorders, particularly those that may substantially affect autonomic state, ECG recording, or interpretation of the primary endpoint, including uncontrolled thyroid dysfunction, uncontrolled diabetes mellitus, significant cerebrovascular disease, neurologic disorders, or active pulmonary disease.
- 5.Presence of significant suicide risk.
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 |
|---|---|---|
| Real repetitive transcranial magnetic stimulationAlso: real rTMSReal rTMS will be delivered to the left dorsolateral prefrontal cortex using the adjusted BeamF3 target. The protocol will consist of 10 Hz stimulation at 100% motor threshold, delivered in 30 cycles, with each cycle including a 5 s train and an 11 s inter-train interval. The total number of pulses will be 1,500. Continuous 3-lead ECG will be recorded during stimulation. | Device | Real rTMS |
| Sham repetitive transcranial magnetic stimulationAlso: sham rTMSSham rTMS will be delivered at the same left dorsolateral prefrontal cortex target as the real-rTMS condition. The coil will be positioned at approximately 45° relative to the scalp to reduce effective cortical stimulation while preserving, as far as possible, the acoustic cue and part of the scalp sensation. Continuous 3-lead ECG will be recorded during the sham protocol. | Device | Sham rTMS |
Primary outcome
the between-group difference in mean HBC across 30 stimulation cycles.
Time frame: Day 1
Heart-brain coupling, HBC, is defined as the power of RR-interval or heart-rate oscillations induced by repeated TMS and locked to the stimulation-cycle frequency at the target frequency, and is used to quantify rhythmic entrainment effects. In this study, HBC is specifically defined as the time-averaged normalized power within the 0.062-0.063 Hz band during each 16 s stimulation cycle. The primary endpoint will be calculated using the Morlet wavelet, with the wavenumber set to the default value of 6 in order to achieve a relative balance between temporal resolution and frequency resolution. For each participant, 30 cycle-specific HBC values will first be obtained, and these 30 values will then be averaged to derive the participant-level mean HBC; this mean will be entered into the between-group comparison as the primary endpoint.
4 secondary outcomes
Mean HBC across 30 stimulation cycles under the higher-frequency-resolution condition.
Time frame: Day 1
Mean HBC across 30 stimulation cycles under the higher-temporal-resolution condition.
Time frame: Day 1
Repeated analysis using the DoG wavelet.
Time frame: Day 1
Repeated analysis using the Paul wavelet.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes
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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.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real repetitive transcranial magnetic stimulation in people with Recurrent Pregnancy Loss and Overweight , Obesity, run by Shenyang Medical College at 1 site 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 5 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: opening soon, as of the sponsor's last update on 1 May 2026. 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 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Tao, MM (86-18802401698, 1939908868@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the between-group difference in mean HBC across 30 stimulation cycles. (time frame: 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 1 May 2026.