Neuroendocrine Mapping of the Cerebral Cortex

Healthy Clinical Trial

Official title:

Endo-Connectome Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04183153
• Other study ID #: 53928
• Status: Withdrawn
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Blood pressure via sphygmomanometer	Measure systolic and diastolic blood pressure (BP) with a sphygmomanometer as a secondary measure of hypothalamic response	3 hours
Secondary	Heart rate via pulse oximeter	Measure heart rate (HR) with a pulse oximeter as a secondary measure of hypothalamic response	3 hours