Menu
Enrolling by invitation NCT05887934

Bone-Lead Level Associations With Brain and Mental Health

— Observational Lead Exposure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: X-Ray Fluorescence Analyzer.
Who it may be relevant to
Registry conditions: Lead Exposure. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Investigation of Bone-Lead Level Associations With Brain and Mental Health and Treatment Response Among MUSC Psychiatry Patients

Overview

The goal of this study is to assess cumulative lead exposure among treatment-seeking patients in the MUSC hospital system receiving experimental transcranial magnetic stimulation (TMS), transcranial direct-current stimulation (tDCS), an electroencephalogram (EEG), and/or transcutaneous auricular vagus nerve stimulation (taVNS) therapies to determine whether lead exposure represents a risk factor for more severe mental illness or a modifier of treatment response. Information will be obtained from patients with a variety of neuropsychiatric disorders recruited to existing hospital studies. This information will include the results of bone-lead testing, brief cognitive tests, and self-reported psychiatric symptoms and behaviors.

Detailed description

The goal of this study is to assess cumulative lead exposure among treatment-seeking patients in the MUSC hospital system receiving experimental transcranial magnetic stimulation (TMS), transcranial direct-current stimulation (tDCS), an electroencephalogram (EEG), and/or transcutaneous auricular vagus nerve stimulation (taVNS) therapies to determine whether lead exposure represents a risk factor for more severe mental illness or a modifier of treatment response. Information will be obtained from patients with a variety of neuropsychiatric disorders recruited to existing hospital studies. This information will include the results of bone-lead testing, brief cognitive tests, and self-reported psychiatric symptoms and behaviors. It is anticipated that the data will serve as preliminary data for research grant applications to support further data collection among a wider clinical and non-clinical population.

Interventions

  • Device X-Ray Fluorescence Analyzer
    The XRF analyzer (the ThermoFisher Niton XL3t GOLDD+) is a portable x-ray fluorescent analyzer specifically configured to measure low levels of metals, lead in particular, in bone. The device is designed to rapidly assess cumulative lead exposure, not to support or sustain human life.

Primary outcome measures

  • Neuropsychiatric Diagnoses [Time frame: Baseline]
  • Cognitive Function [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age 18-70
  • Ability to read, write, and comprehend English
  • Capacity to consent
  • Consented for recontact, when applicable
  • Negative pregnancy test

Additional inclusion criteria match those of parent studies, including:

  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience (PRO 102709)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-TMS) for the Treatment of Post-Partum Depression (PRO 73886)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose-finding Study (PRO 82315)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve (PRO 84111)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum (PRO 106843)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Sign vs. Goal Tracking in Alcohol Use Disorder: Predicting problem alcohol use using a neurophysiological endophenotype of reward-based incentive salience attribution (PRO 124775)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Transcranial Magnetic Stimulation and Decision Making (PRO 126644)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in The Influence of Mental States on Anticipation and Processing of Emotional Information (PRO 94001)
  • Currently meets all inclusion criteria, has agreed to be recontacted, and has consented to participate in Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning (PRO 107689)

Exclusion criteria

  • Pregnant
  • Current schizophrenia or psychotic disorder
  • Inability or unwillingness of subject to give informed consent

Additional exclusion criteria match those of parent studies, including:

  • Currently does not meet any exclusion criteria from MPFC Theta Burst Stimulation as a Treatment Tool for Alcohol Use Disorder: Effects on Drinking and Incentive Salience (PRO 102709)
  • Currently does not meet any exclusion criteria from An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-TMS) for the Treatment of Post-Partum Depression (PRO 73886)
  • Currently does not meet any exclusion criteria from Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose-finding Study (PRO 82315)
  • Currently does not meet any exclusion criteria from Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve (PRO 84111)
  • Currently does not meet any exclusion criteria from Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum (PRO 106843)
  • Currently does not meet any exclusion criteria from Sign vs. Goal Tracking in Alcohol Use Disorder: Predicting problem alcohol use using a neurophysiological endophenotype of reward-based incentive salience attribution (PRO 124775)
  • Currently does not meet any exclusion criteria from Transcranial Magnetic Stimulation and Decision Making (PRO 126644)
  • Currently does not meet any exclusion criteria from The Influence of Mental States on Anticipation and Processing of Emotional Information (PRO 94001)
  • Currently does not meet any exclusion criteria from Optimizing Transdiagnostic Non-invasive Vagus Nerve Stimulation to Enhance Learning (PRO 107689)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Identifiers

NCT: NCT05887934 · Pro00126756

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗