Neuroendocrine Mapping of the Cerebral Cortex

Study Overview
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Brief Summary
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This study is investigating brain regions that share functional connectivity with the hypothalamus and the stimulation of those regions using repetitive transcranial magnetic stimulation (rTMS) to activate the hypothalamus indirectly. The goal of this study is to determine the effectiveness of rTMS in influencing the hypothalamus to better understand the mechanisms between it and the neuroendocrine processes it controls.

Official Title
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Endo-Connectome Study

Conditions
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Healthy

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 21-55 Gender: Females and Males Weight: Less than 280 pounds Mobile Normal vision with corrective lenses if necessary Fluent in English (written and spoken) Exclusion Criteria: History of epilepsy/seizures (including history of withdrawal/provoked seizures) Metal implant in brains (e.g. deep stimulation), cardiac pacemaker, or cochlear implants Shrapnel or any ferromagnetic item in the head Showing symptoms of withdrawal from alcohol or benzodiazepines Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation) Migraine or significant headaches Shoulder or neck stiffness Over 280 pounds In-dwelling ferrous metals Left handed Abnormal hearing Abnormal vision that cannot be corrected with lenses Claustrophobia Illicit drug use Psychotropic medication use Marijuana and/or nicotine use Psychiatric or neurological conditions Endocrine conditions History of head trauma with loss of consciousness

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Arm<br> | Device: Repetitive Transcranial Magnetic Stimulation<br>* Participants will receive repetitive transcranial magnetic stimulation (rTMS) to determine if stimulating areas with activating functional connectivity will activate the hypothalamus and in turn, have a measurable effect on hormone levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GnRH levels resulting from hypothalamus activation via LC-MS | Measure levels of the gonadotropin-releasing hormone (GnRH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma vasopressin levels via LC-MS | Measure levels of the vasopressin hormone in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma oxytocin levels via LC-MS | Measure levels of the oxytocin hormone in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma TRH levels via LC-MS | Measure levels of the thyrotropin-releasing hormone (TRH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma CRH levels via LC-MS | Measure levels of the corticotropin-releasing hormone (CRH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma somatostatin levels via LC-MS | Measure levels of the somatostatin hormone, or growth hormone-inhibiting hormone (GHIH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma PRLH levels via LC-MS | Measure levels of the prolactin-releasing hormone (PRLH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma FSH levels via LC-MS | Measure levels of the follicle-stimulating hormone (FSH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma LH levels via LC-MS | Measure levels of the luteinizing hormone (LH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma ACTH levels via LC-MS | Measure levels of the adrenocorticotropic hormone (ACTH) in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 
| Plasma cortisol levels via LC-MS | Measure levels of the cortisol hormone in blood plasma through liquid chromatography-mass spectrometry (LC-MS) resulting from hypothalamus and neuroendocrine activation | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure via sphygmomanometer | Measure systolic and diastolic blood pressure (BP) with a sphygmomanometer as a secondary measure of hypothalamic response | 3 hours | 
| Heart rate via pulse oximeter | Measure heart rate (HR) with a pulse oximeter as a secondary measure of hypothalamic response | 3 hours |