NCT05887934

Bone-Lead Level Associations With Brain and Mental Health

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Lead Exposure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-17
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-06-05
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States