Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Maternal Care Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Maternal Care Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Maternal Care Rating Scale
时间窗: 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).
次要结局
未报告次要终点