Neuroendocrine Mapping of the Cerebral Cortex

Not Applicable

Withdrawn

• Conditions: Healthy
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT04183153
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-25
• Study First Submitted QC: 2019-11-27
• Study First Posted: 2019-12-03
• Study Start: 2020-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Arm	Repetitive Transcranial Magnetic Stimulation	-

Primary Outcome Measures

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

Secondary Outcome Measures

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