Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment

NCT06743724 | Completed

• 2 other identifiers: No.2024-11732230041
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Maternal Care Patterns; Repetitive Transcranial Magnetic Stimulation (rTMS); Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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).

  End of the 2-week treatment

Study Arms (2)

Repeated transcranial magnetic stimulation group

ACTIVE COMPARATOR

The rTMS group was given 1 Hz/s for 20 min for 2 week.

Device: rTMS group

Sham repetitive transcranial magnetic stimulation group

SHAM COMPARATOR

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

Interventions

rTMS group 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

Repeated transcranial magnetic stimulation group

Sham device 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.

Sham repetitive transcranial magnetic stimulation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soochow University: collaborator
• The First Affiliated Hospital of Soochow University: lead

Study Sites (2)

The First Affiliated Hospital of Soochow University

Suzhou, China, 215006, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Guangyin Xu, Prof.

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 20, 2024
• Study Start: June 14, 2024
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)