Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment

May 29, 2026 updated by: The First Affiliated Hospital of Soochow University

Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Maternal Care Impairment (MCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • China
      • Suzhou, China, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Healthy mothers.
  • Aged between 18 and 45 years.
  • No pharmacological treatment (excluding emergency treatment) for at least 2 weeks prior to the start of treatment; cannot be enrolled in other clinical trials simultaneously.
  • Voluntarily sign the informed consent form and willingly participate in the clinical study.

Exclusion Criteria:

  • Age below 18 years or above 45 years.
  • Unmarried, nulliparous women.
  • Individuals with severe liver, kidney, hematological diseases, cardiovascular diseases, or other conditions that significantly affect cognitive function.
  • Participants with a clear history of organic diseases, or systemic conditions such as diabetes, hyperthyroidism, etc.
  • Participants undergoing other treatments or taking medications that may interfere with the outcome assessment.
  • Pregnant women, breastfeeding women, or women within six months postpartum.
  • Individuals with severe needle phobia, metal allergies, or allergic conditions, or those with a cardiac pacemaker.
  • Participants who do not comply with random group assignment or have unstable tendencies such as poor adherence.
  • Individuals currently participating in other research studies.
  • Individuals unwilling to sign the informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Repeated transcranial magnetic stimulation group
The rTMS group was given 1 Hz/s for 20 min for 2 week.
Device: rTMS group
Patients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Other Names:
  • transcranial magnetic stimulation
Sham Comparator: Sham repetitive transcranial magnetic stimulation 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Care Rating Scale
Time Frame: End of the 2-week treatment
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).
End of the 2-week treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Soochow University

Investigators

  • Principal Investigator: Guangyin Xu, Prof., The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2024

Primary Completion (Actual)

April 9, 2026

Study Completion (Actual)

April 9, 2026

Study Registration Dates

First Submitted

December 7, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.2024-117
  • 32230041 (Other Grant/Funding Number: National Natural Science Found)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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