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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Transcranial magnetic stimulation of the expected dose will occur |
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| Sham | Sham Comparator | No transcranial magnetic stimulation of the expected dose will be applied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marom Bikson, PhD | The City College of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | New York | New York | 10010 | United States |
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This is a single-blind sham controlled trial
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| 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. |
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| Baseline and immediately post-intervention |