RECRUITING

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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....

Official Title

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Quick Facts

Study Start:2003-10-24
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01036581

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and non-pregnant female adults between the ages of 18-80.
  2. * All subjects must be able to provide informed consent.
  1. * Are pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.
  2. * 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.
  3. * 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.
  4. * Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders.
  5. * 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.
  6. * 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.
  7. * Are cognitively impaired, as assessed by the consent quiz and 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.
  8. * 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)
  9. * left-handedness (if desired for a particular task)
  10. * color-blindness (if using a task requiring color discrimination)
  11. * drug use diagnosis
  12. * use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used)

Contacts and Locations

Study Contact

NIDA IRP Screening Team
CONTACT
(800) 535-8254
researchstudies@nida.nih.gov
Yihong Yang, Ph.D.
CONTACT
(667) 312-5364
yihongyang@intra.nida.nih.gov

Principal Investigator

Yihong Yang, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute on Drug Abuse (NIDA)

Study Locations (Sites)

National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

  • Yihong Yang, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Drug Abuse (NIDA)

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 Registration Dates

Study Start Date2003-10-24
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2003-10-24
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Magnetic Resonance Imaging (MRI)
  • Functional Brain Imaging
  • Magnetic Resonance Spectroscopy
  • Diffusion Tensor Imaging
  • Drug Abuse

Additional Relevant MeSH Terms

  • Drug Abuse
  • Nicotine Dependence