Lead ExposureNCT05887934
Bone-Lead Level Associations With Brain and Mental Health
An observational study of Lead Exposure, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Exposure
- What is being tested?
- X-Ray Fluorescence Analyzer
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2023to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 15Show fewer
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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
- Being tested
- X-Ray Fluorescence Analyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-Ray Fluorescence AnalyzerDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric Diagnoses
Count of participants varying neuropsychiatric disorders assessed by the Diagnostic Interview for Anxiety, Mood, and OCD and related Neuropsychiatric Disorders (DIAMOND)
Measured: Baseline
Cognitive Function
Measurement of cognitive function as assessed by the Trail Making Test (TMT) as a way to assess central executive functioning.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start17 Aug 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lead ExposureStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Kilpatrick, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887934
- Sponsor's protocol ID
- Pro00126756
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Bone-Lead Level Associations With Brain and Mental Health and Treatment Response Among MUSC Psychiatry Patients
- ClinicalTrials.gov ID
- NCT05887934
- Acronym / sponsor ID
- Pro00126756
- Conditions
- Lead Exposure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Age 18-70
- Ability to read, write, and comprehend English
- Capacity to consent
- Consented for recontact, when applicable
- Negative pregnancy test
Key exclusion criteria (13 listed)
- Pregnant
- Current schizophrenia or psychotic disorder
- Inability or unwillingness of subject to give informed consent
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-Ray Fluorescence AnalyzerThe 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. | Device | – |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Lead Exposure
Recruiting
Reducing Lead Dust Exposure in Older Housing
Exposure to Toxic Dust, Elevated Blood Lead Levels
Not yet recruiting
Lead Exposure Intervention Program
Lead Exposure, High Blood Lead Level
Not yet recruiting
A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
Lead Poisoning, Environmental Exposure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dean Kilpatrick, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lead Exposure, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Diagnoses (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.