Bone-Lead Level Associations With Brain and Mental Health

October 10, 2023 updated by: Dean Kilpatrick, Medical University of South Carolina

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Dean Kilpatrick, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Diagnoses
Time Frame: Baseline
Count of participants varying neuropsychiatric disorders assessed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders (DIAMOND)
Baseline
Cognitive Function
Time Frame: Baseline
Measurement of cognitive function as assessed by the Trail Making Test (TMT) as a way to assess central executive functioning.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Dean Kilpatrick, Ph.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00126756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lead Exposure

Clinical Trials on X-Ray Fluorescence Analyzer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe