An interventional study of Real repetitive transcranial magnetic stimulation and Sham repetitive transcranial magnetic stimulation in Recurrent Pregnancy Loss, Overweight , Obesity and Heart-Brain Coupling, sponsored by Shenyang Medical College. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Shenyang Medical College · Not applicable, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 60 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Shenyang Medical College is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Real repetitive transcranial magnetic stimulation
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.
Device: Sham repetitive transcranial magnetic stimulation
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.
Also known as: real 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.
Also known as: sham rTMS
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
General adverse events during rTMS
General adverse events will be recorded during the rTMS-ECG protocol and the 1 h post-protocol observation period. Events of interest will include pain at the stimulation site, scalp discomfort, facial muscle contraction, mild headache, and dizziness. Each event will be documented by type, occurrence, timing, and clinical management if applicable.
Time frame: Day 1
Serious adverse events during rTMS
Serious adverse events will be recorded during the rTMS-ECG protocol and the 1 h post-protocol observation period. Events of interest will include syncope and seizure. Each event will be documented by type, occurrence, timing, severity, clinical management, and outcome if applicable.
Time frame: Day 1
Plan to share: Yes
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Sep 2026, 5 months later.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 5 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Shenyang Medical College