NCT01036581 · National Institute on Drug Abuse (NIDA)
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
What this study is about
Background: \- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes.
View original scientific description
Background: \- Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes. To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain. Objectives: \- To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction. Eligibility: * Individuals between 18 and 80 years of age. * Participants may be smokers or nonsmokers, and may use drugs or not use drugs. Design: * During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers. Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session. * Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide. Participants will also provide blood samples before the start of the scan. * For each scanning session, participants will have an MRI scan that will last approximately 2 hours. * MRI scans may include specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide....
Interventions
DEVICE
MagPro X100 Magnetic Stimulator
Concurrent TMS-MRI acquisition allows us to investigate the acute effects of induced brain activity on BOLD signal and evaluate interference of the TMS pulse with the BOLD signal measurement.
DEVICE
Transcranial Rotating Magnetic Stimulator
Participants will undergo transcranial rapid rotating permanent magnetic stimulation (TRPMS), with the aim of evaluating the prolonged effect of TRPMS on motor cortex excitability. In another experiment, participants will undergo TRPMS with the aim of evaluating cortical excitability changes with TRPMS. These experiments will help interpret subsequent experiments investigating the effect of TRPMS on BOLD signal.
DEVICE
Magnetom Prisma Fit 3T Scanner
Type: MRI Name: Magnetom Prisma Fit 3T Scanner (Siemens) Description: Functional and structural magnetic resonance imaging techniques are used for noninvasive mapping of brain physiology and pathology and to develop advanced magnetic resonance imaging and spectroscopy (MRI and MRS) techniques for neuroimaging studies related to addiction.
Primary outcome measures
To develop a simultaneous perfusion and BOLD imaging technique with improved functional contrasts and reduced susceptibility artifacts for determination of CMRO2 during brain activation
Time frame: at each visit
perfusion/BOLD imaging data
To develop efficient methods to reduce image artifacts caused by susceptibility-induced field inhomogeneity and head motion, and therefore to improve reliability and sensitivity of functional imaging
Time frame: at each visit
MRI scan data
To develop an imaging technique to identify fiber crossing in the brain based on high-angular resolution measurements of apparent diffusion coefficient (ADC), and subsequently to develop improved fiber tracking techniques to delineate neuronal p...
Time frame: at each visit
MRI scan data
To develop MRS techniques that are able to reliably measure metabolite and neurotransmitter concentrations in the brain at 3 Tesla, and to evaluate their feasibility and efficacy in drug addiction studies
Time frame: at each visit
MRS data from MRI scans
To integrate genetic analysis with morphological and functional measurement of the amygdala, hippocampus, and other regions, which may help to account for some of the noise in these measurements
Time frame: at each visit
MRI scan data and blood samples collected in 380 or 457 (NRB genetics protocol).
To assess effects of neuromodulation techniques, such as TMS and TRPMS, on brain activity and relevant MRI signals
Time frame: at each visit
MRI scan data; spontaneous motor unit potentials (sMUPs) in the contralateral abductor pollicis brevis muscle (APB)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and non-pregnant female adults between the ages of 18-80.
- All subjects must be able to provide informed consent.
Exclusion criteria
- Subjects will be excluded if they:
- Are pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.
- Are unable to undergo MRI scanning due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts including Copper 7 IUD) or claustrophobia.
- Have major medical illnesses severe enough to impact data being gathered. Potential exclusions may include a history of chronic uncontrolled hypertension, diabetes, HIV, or other clinically significant medical conditions that may alter the signal being measured.
- Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders.
- Have neurological illnesses severe enough to impact data being gathered. Potential exclusions may include seizure disorders, migraine, multiple sclerosis, movement disorders, or history of significant head trauma, CVA, or CNS tumor. The MAI will assess the severity in relation to the potential impact on data.
- Are non-English speaking. Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS/TRPMS procedures. The inability to effectively communicate MRI and TMS/TRPMS safety procedures could compromise the safety of non-English speaking participants.
- Are cognitively impaired, as assessed by medical history. A validated IQ test such as the WASI or Shipley-2 may also be considered. Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data. Cognitive impairment may affect one s ability to give informed consent. Subjects to be considered for Non-Invasive Brain Stimulation (NIBS) will also be excluded if they: -Are unable to safely undergo a NIBS procedure as assessed by a TMS safety screening form. Additional information will be gathered during screening for some experiments. As the purpose of this protocol is to develop imaging techniques, this information will be gathered as needed, depending on the phase of development and specific technique requirements. Based on the scientific and medical requirements of the particular experiment, participants may also be assessed for:
- Age (some experiments may want to target a particular age range. For example, cognitive tasks generally exclude participants over 60, an age when cognitive issues tend to become more commonplace)
- Left-handedness (if desired for a particular task)
- Color-blindness (if using a task requiring color discrimination)
- Drug use diagnosis
- Use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used). MAI discretion regarding timeframe of allowed use will be based on clinically relevant factors including drug half-life, pharmacology of the drug in question and pattern of use by the participant.
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations