Neuroendocrine Mapping of the Cerebral Cortex

Sponsor

Stanford University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04183153

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Repetitive Transcranial Magnetic Stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Endo-Connectome Study

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 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 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 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 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 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 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 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
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 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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Keith Sudheimer, Ph.D., Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04183153

Other Study ID Numbers:

53928

First Posted:

Dec 3, 2019

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 6, 2021