Neuroendocrine Mapping of the Cerebral Cortex

NCT04183153 | Withdrawn

• 1 other identifier: 53928
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Blood pressure via sphygmomanometer

  3 hours

• Heart rate via pulse oximeter

  3 hours

Study Arms (1)

Healthy Arm

EXPERIMENTAL

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Healthy Arm

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Keith Sudheimer, Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 3, 2019
• Study Start: August 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share