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Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI
Sponsor: Shenyang Medical College
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. 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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-28
Completion Date
2026-09-30
Last Updated
2026-05-01
Healthy Volunteers
No
Interventions
Real 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.
Sham repetitive transcranial magnetic stimulation
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.
Locations (1)
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China