Neuroendocrine Mapping of the Cerebral Cortex

Endo-Connectome Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Arm	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Keith Sudheimer, Ph.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 53928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No