TMS-Induced LH Response in Healthy Women in Luteal Phase

NCT07363421 | Active Not Recruiting FDA Device

• 1 other identifier: 2025-0871-CCNY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Women

Keywords

LH; FSH; TMS; Blood samples; Hormones

Outcome Measures

Primary Outcomes (1)

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

  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.

  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).

Secondary Outcomes (1)

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

  Baseline and immediately post-intervention

Study Arms (2)

Active

ACTIVE COMPARATOR

Transcranial magnetic stimulation of the expected dose will occur

Device: Transcranial Magnetic Stimulation Active

Sham

SHAM COMPARATOR

No transcranial magnetic stimulation of the expected dose will be applied

Device: Transcranial Magnetic Stimulation Sham

Interventions

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.

Active

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.

Sham

Eligibility Criteria

• Age: 22 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The City College of New York: lead

Study Sites (1)

Site 1

New York, New York, 10010, United States

Location

Study Officials

• Marom Bikson, PhD

  The City College of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a single-blind sham controlled trial

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 23, 2026
• Study Start: February 24, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)