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Clinical Trials/NCT04183153
NCT04183153
Withdrawn
Not Applicable

Endo-Connectome Study

Stanford University0 sitesAugust 2020
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Stanford University
Primary Endpoint
Plasma GnRH levels resulting from hypothalamus activation via LC-MS
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2020
End Date
December 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age: 21-55
  • Gender: Females and Males
  • Weight: Less than 280 pounds
  • 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

Outcomes

Primary Outcomes

Plasma GnRH levels resulting from hypothalamus activation via LC-MS

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Heart rate via pulse oximeter(3 hours)
  • Blood pressure via sphygmomanometer(3 hours)

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