Healthy Women
Conditions
Keywords
LH, FSH, TMS, Blood samples, Hormones
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.
Interventions
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.
DEVICETranscranial 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.
Sponsors
The City College of New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Intervention model description
This is a single-blind sham controlled trial
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Schedule - Short Form (PANAS-SF) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMarom Bikson, PhD
The City College of New York
Outcome results
None listed