Repeated Transcranial Magnetic Stimulation Relieves Maternal Care Impairment
NCT ID: NCT06743724
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-06-14
2026-01-30
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Low-score group
The low-score group received rTMS at 1 Hz for 20 minutes per session, once daily, for a duration of 2 weeks.
repeated transcranial magnetic stimulation treatment
Patients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Interventions
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repeated transcranial magnetic stimulation treatment
Patients with low score of Maternal Care Rating Scale received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
45 Years
FEMALE
Yes
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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Guangyin Xu
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, China
Countries
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Other Identifiers
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No.2024-117
Identifier Type: -
Identifier Source: org_study_id