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NCT Number: NCT07363421

TMS-Induced LH Response in Healthy Women in Luteal Phase

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Women

Age range

22 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Site 1

New York, 10010, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation Active

Device

Participants will receive stimulation to the left DLPFC.

Stimulation intensity will be standardized based on resting motor threshold.

Stimulation will be delivered using NeuroStar system.

Transcranial Magnetic Stimulation Sham

Device

Participants will undergo identical procedure to the active TMS group, including coil placement, session duration, and acoustic and somatic sensations. A sham device setting will be used that mimics the sound but does not deliver an effective magnetic field to the DLPFC.

Primary outcomes

  1. Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels

    Time frame: 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.

Secondary outcomes

  1. Positive and Negative Affect Schedule - Short Form (PANAS-SF)

    Time frame: Baseline and immediately post-intervention

    The PANAS-SF is a self-report questionnaire assessing momentary positive and negative affect. It consists of 20 adjectives (10 positive, 10 negative) rated on a Likert scale (e.g., 1 = very slightly or not at all to 5 = extremely). Separate positive affect and negative affect subscale scores are calculated by summing the relevant items; higher scores indicate greater intensity of that affect dimension.

Sponsors and collaborators

Lead sponsor

The City College of New York

Other

Registry information

Official study title

Feasibility Study Protocol: TMS-Induced LH Response in Healthy Women in the Luteal Phase

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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