Feasibility Study Protocol: TMS-Induced LH Response in Healthy Women in the Luteal Phase
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels
研究概览
简要总结
The purpose of this research is to establish whether non-invasive Transcranial Magnetic Stimulation (TMS), can affect modulation of hormones such: Luteinizing Hormone (LH) and Follicle-stimulating hormone (FSH).
The hypothesis is that applying TMS to the Dorsolateral Prefrontal Cortex with specific pulse patterns, mimicking endogenous Gonodotropin-Releasing Hormone (GnRH) pulses that are known to stimulate LH secretion may modulate hormonal levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women aged 22-40 years with regular menstrual cycle.
- •In luteal phase at the time of visit.
排除标准
- •Presence of any known structural brain abnormalities or tumors.
- •Presence of metal implants/devices in the head or neck.
- •Has ever had a stroke, seizure, or has a family history of epilepsy.
- •Head injury with loss of consciousness.
- •Use of hormonal contraceptives in the past 3 months.
- •Irregular menstrual cycles.
- •Diagnosed with a reproductive system disorder (e.g., PCOS, endometriosis, infertility, hypogonadism).
- •History of endocrine disorders such diabetes mellitus, thyroid disease, adrenal disorders, pituitary tumor or others.
- •Been diagnosed or received treatment for depression, anxiety disorder, schizophrenia, PTSD or bipolar disorder.
- •Have a history of medical disorder such liver or renal impairment, HIV/AIDS or unstable cardiac disease.
- •Taking any medications that affect the central nervous system such as antidepressents, antipsychotics, GLP-1 receptor agonists or hormone therapies.
- •Are you pregnant, planning pregnancy or breastfeeding.
- •Have experienced difficulties in the past during blood draws such as locating the vein, fainting or other adverse reactions.
- •Have any sleep disorder such as insomnia or sleep apnea.
- •Have fear of needles or the sight of blood.
- •Underwent TMS stimulation in the past and had difficulties.
研究组 & 干预措施
Active
Transcranial magnetic stimulation of the expected dose will occur
干预措施: Transcranial Magnetic Stimulation Active (Device)
Sham
No transcranial magnetic stimulation of the expected dose will be applied
干预措施: Transcranial Magnetic Stimulation Sham (Device)
结局指标
主要结局
Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels
时间窗: Six blood draws per participant: Baseline 1 (30 minutes pre-TMS), Baseline 2 (immediately pre-TMS), T1 (20 minutes post-TMS), T2 (55 minutes post-TMS), T3 (20 minutes post-second TMS), T4 (55 minutes pos-second TMS).
Change in serum LH and FSH concentrations across six time points. Blood samples will be collected via venipuncture. LH and FSH levels will be quantified in IU/L. The primary analysis will evaluate within-subject changes in LH and FSH across the six sampling points and compare hormonal trajectories between active TMS and sham.
次要结局
- Positive and Negative Affect Schedule - Short Form (PANAS-SF)(Baseline and immediately post-intervention)
研究者
Marom Bikson
Professor
The City College of New York