Healthy WomenNCT07363421
TMS-Induced LH Response in Healthy Women in Luteal Phase
A study testing Transcranial Magnetic Stimulation Active in people with Healthy Women, run by The City College of New York at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Transcranial Magnetic Stimulation Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women aged 22-40 years with regular menstrual cycle.
- In luteal phase at the time of visit.
Who cannot join
- 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.
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Women
- Being tested
- Transcranial Magnetic Stimulation Active, Transcranial Magnetic Stimulation Sham
- Keywords
- LH, FSH, TMS, Blood samples, Hormones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation ActiveDevice
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 ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Transcranial magnetic stimulation of the expected dose will occur Receives: Device: Transcranial Magnetic Stimulation Active |
| Sham | Sham comparator | No transcranial magnetic stimulation of the expected dose will be applied Receives: Device: Transcranial Magnetic Stimulation Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start24 Feb 2026
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind sham controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marom Bikson, The City College of New York
- Investigators
- Marom Bikson, PhD, Principal investigator, The City College of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363421
- Sponsor's protocol ID
- 2025-0871-CCNY
- Status last verified
- Apr 2026
- First submitted
- 21 Jan 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Protocol: TMS-Induced LH Response in Healthy Women in the Luteal Phase
- ClinicalTrials.gov ID
- NCT07363421
- Acronym / sponsor ID
- 2025-0871-CCNY
- Conditions
- Healthy Women
- Keywords
- LH, FSH, TMS, Blood samples, Hormones
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-blind sham controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: Transcranial Magnetic Stimulation ActiveTranscranial magnetic stimulation of the expected dose will occur |
| Sham | Sham comparator | Device: Transcranial Magnetic Stimulation ShamNo transcranial magnetic stimulation of the expected dose will be applied |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women aged 22-40 years with regular menstrual cycle.
- In luteal phase at the time of visit.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation ActiveParticipants will receive stimulation to the left DLPFC. Stimulation intensity will be standardized based on resting motor threshold. Stimulation will be delivered using NeuroStar system. | Device | Active |
| Transcranial Magnetic Stimulation ShamParticipants 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. | Device | Sham |
Primary outcome
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.
1 secondary outcome
Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Time frame: Baseline and immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Women
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 1
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
Participants With Moderate and Severe Renal Impairment and Healthy Participants
Recruiting
The Effect of Water Temperature on Heart Rate Variability and Cognition
Mental Acuity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marom Bikson, PhD principal investigator
The City College of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation Active in people with Healthy Women, run by The City College of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.