TMS-Induced LH Response in Healthy Women in Luteal Phase

The City College of New York

Status: Not yet enrolling

Conditions: Healthy Women

Treatments: Device: Transcranial Magnetic Stimulation Active; Device: Transcranial Magnetic Stimulation Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT07363421

2025-0871-CCNY

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 22 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women aged 22-40 years with regular menstrual cycle.
• In luteal phase at the time of visit.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Active

Active Comparator group

Description:

Transcranial magnetic stimulation of the expected dose will occur

Treatment:

Device: Transcranial Magnetic Stimulation Active

Sham

Sham Comparator group

Description:

No transcranial magnetic stimulation of the expected dose will be applied

Treatment:

Device: Transcranial Magnetic Stimulation Sham