Bone-Lead Level Associations With Brain and Mental Health

NCT05887934 | Enrolling By Invitation

• 1 other identifier: Pro00126756
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lead Exposure

Outcome Measures

Primary Outcomes (2)

• Neuropsychiatric Diagnoses

  Count of participants varying neuropsychiatric disorders assessed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders (DIAMOND)

  Baseline

• Cognitive Function

  Measurement of cognitive function as assessed by the Trail Making Test (TMT) as a way to assess central executive functioning.

  Baseline

Interventions

X-Ray Fluorescence Analyzer DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The current study will recruit solely from research studies listed within the inclusion/exclusion criteria. The populations within the inclusion/exclusion criteria cover a wide range of psychiatric disorders including but not limited to alcohol use disorder (AUD), major depressive disorder (MDD), and anxiety spectrum disorders (ASD). There will be no exclusion based on gender or minority status. The investigators anticipate that at least 50% of the participants will be women. The percentage of minority participants is expected to be at least 5%. The investigators will make vigorous attempts to increase this number by posting advertisement flyers in minority communities.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

• Dean Kilpatrick, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: June 5, 2023
• Study Start: August 17, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)