Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment

NCT06743724 | Active Not Recruiting

• 1 other identifier: No.2024-117
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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).

  1 week of treatment

Study Arms (1)

Low-score group

EXPERIMENTAL

The low-score group received rTMS at 1 Hz for 20 minutes per session, once daily, for a duration of 2 weeks.

Device: repeated transcranial magnetic stimulation treatment

Interventions

repeated transcranial magnetic stimulation treatment 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.

Low-score group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006, China

Location

Study Officials

• Guangyin Xu

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)