TMS-Induced LH Response in Healthy Women in Luteal Phase

April 24, 2026 updated by: Marom Bikson, The City College of New York

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Site 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active
Transcranial magnetic stimulation of the expected dose will occur
Device: Transcranial Magnetic Stimulation Active

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.
Sham Comparator: Sham
No transcranial magnetic stimulation of the expected dose will be applied
Device: Transcranial Magnetic Stimulation Sham
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The City College of New York

Investigators

  • Principal Investigator: Marom Bikson, PhD, The City College of New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-0871-CCNY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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