An interventional study of rTMS group and Sham device in Repetitive Transcranial Magnetic Stimulation (rTMS), Functional Magnetic Resonance Imaging and Maternal Care Patterns, sponsored by The First Affiliated Hospital of Soochow University. Completed at 2 sites in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by The First Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment
Objective: To evaluate the overall efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of maternal care impairment (MCI) and to explore the central mechanism of rTMS for MCI.
Design: Combined functional magnetic resonance imaging (fMRI) with Maternal Care Rating Scale (MCRS) were used to pinpoint hyperactive brain regions of patients with low MCRS score. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in low MCRS score patients.
Background: Emotional dysregulation in patients with maternal care impairment represents a significant therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving these negative emotional states and their suitability as neuromodulatory targets remain undefined.
Methods: Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed. Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the anterior cingulate cortex (ACC) with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized.
For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.
The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The rTMS group was given 1 Hz/s for 20 min for 2 week.
Device: rTMS group
For the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
Device: Sham device
Patients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Also known as: transcranial magnetic stimulation
For the sham rTMS group, the coil was placed over the ACC with the rTMS function disabled and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
Maternal Care Rating Scale
The Maternal Care Rating Scale (MCRS) is a tool designed to assess and evaluate the quality of maternal care, including aspects of maternal behavior, emotional responses, and caregiving abilities. It focuses on the mother's ability to engage in positive, nurturing, and responsive interactions with her child. The scale can help identify variations in maternal care, such as maternal sensitivity, emotional support, and overall caregiving competence. In research, it is often used to measure the effectiveness of interventions aimed at improving maternal behavior or addressing maternal deficits, such as maternal care impairment (MCI).
Time frame: End of the 2-week treatment
Plan to share: No — This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Soochow University