Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06743724
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

Objective: To evaluate the overall efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of maternal care impairment and to explore the central mechanism of rTMS for maternal care impairment.

Methods: Fifty participants meeting the inclusion criteria were divided into high-score and low-score groups based on the Maternal Care Rating Scale (MCRS). Participants in the low-score group received rTMS treatment (1 Hz, 20 minutes per session, once daily) for two weeks. Functional magnetic resonance imaging (fMRI) and MCRS assessments were conducted both before and after the treatment to evaluate changes. Additionally, in the high-score group, fMRI was used to assess functional changes in specific brain regions.

Detailed Description

A substantial body of literature has reported that repetitive transcranial magnetic stimulation (rTMS) can alleviate negative emotions. The underlying mechanisms include its ability to modulate cortical excitability, enhance cerebral blood flow and metabolism, regulate neurotransmitter and gene expression, and promote neuroplastic changes in the nervous system.

Methods:

1. Fifty recruited volunteers were divided into high-score and low-score groups based on the Maternal Care Rating Scale (MCRS). Functional magnetic resonance imaging (fMRI) was used to assess differences in brain function between the two groups.

2. The low-score group underwent a two-week intervention with repetitive transcranial magnetic stimulation (rTMS) (1 Hz, 20 minutes per session, once daily). The MCRS served as the primary outcome measure to evaluate treatment efficacy. Additionally, fMRI was performed to compare pre- and post-treatment changes in brain function. The functional magnetic resonance data of both the high-score and low-score groups were analyzed using the amplitude of low-frequency fluctuation (ALFF) method and the regional homogeneity (ReHo) method to identify differences in brain function. For the low-score group, changes in ALFF and ReHo values in specific brain regions before and after treatment were compared. These changes were correlated with the improvement values of the clinical observation index to identify target brain areas that mediate the effects of rTMS.

Study Timeline

• Study Start: 2024-06-14
• Status Verified: 2024-12
• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maternal Care Rating Scale	1 week of 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).

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China