Cognitive Task Development and Implementation for Functional MRI Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01036685
First received: December 18, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

Background:

  • Drugs of abuse have effects on mood, behavior, thinking, and decision making that may encourage people to continue using them and make it difficult for them to stop. Researchers who study these effects are interested in developing new tests to evaluate how drugs and drug use affect different areas of the brain.
  • Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and changes to brain function. When specific psychological tests are performed during functional MRI (fMRI) scans, researchers can examine the effects of drug use on the brain. By developing and testing new procedures for fMRI studies, more information can be obtained on brain function and activity in drug-using and non-drug-using individuals, and this information can help develop new treatments and therapies for substance abuse.

Objectives:

- To evaluate the effects of newly developed psychological procedures to be performed during fMRI scans.

Eligibility:

  • Healthy volunteers between 13 and 55 years of age who are willing to undergo MRI scanning.
  • Both drug-using and non-drug-using individuals will be selected for this study.

Design:

  • Before the start of the study, participants will complete questionnaires about medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed during the scanning session(s), and will allow participants to practice the test either on a separate computer or on the computer used during the MRI scan.
  • During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks will be performed on a computer in an MRI machine, and may involve receiving rewards (such as money or sips of juice) for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen.
  • Participants will receive compensation for their participation in the study, including hourly compensation for individual visits and lump-sum compensation for each MRI scan.

Condition
Drug Abuse

Study Type: Observational
Official Title: Cognitive Task Development and Implementation for Functional MRI Studies

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 750
Study Start Date: May 2003
Detailed Description:

Objective: Drugs of abuse have cognitive and affective effects that may contribute to the inception and maintenance of their use. In order to measure these effects, psychological tests suitable for use both in and outside the fMRI scanner need to be developed and validated. Thus, the objective of this protocol is to allow for the development, assessment and refinement of cognitive and affective tasks and determination of their practical feasibility and efficacy for both MRI and non-MRI application.

The design and piloting of psychological tests and fMRI tasks specifically designed for an adolescent population allows the investigators to determine if the tests/tasks measure theorized cognitive constructs and result in measurable and interpretable fMRI data in adolescents.

Study Population: This minimal-risk protocol will employ volunteer participants aged 13-55, who must be generally healthy and male or non-pregnant female. In order to ensure applicability to relevant groups, both drug and non-drug using volunteers as well as those recruited from clinical populations at the institutions of IRB approved collaborating investigators will be used to validate task design and parameters.

Design: Participants may pilot tasks outside and/or inside the MRI scanner, depending on the aspects of task development requiring verification. Tasks developed de novo will undergo both steps. Modifications to previously published MRI tasks may require only one of the steps. Upon their successful verification, specific experimental manipulations will be performed under separate, hypothesis driven protocols.

Outcome measures: Our goal is to determine if the tasks developed reliably and appropriately measure specific cognitive constructs and behaviors thought to be associated with specific brain systems and, also if they yield measurable and interpretable fMRI results.

  Eligibility

Ages Eligible for Study:   13 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

    1. Male and non-pregnant female between the ages of 13-55. (Pregnancy not an exclusion for Level 1 and Level 2 pilot studies).
    2. All subjects must be able to provide informed consent/assent. Minors must have a parent/guardian able to provide informed consent.

EXCLUSION CRITERIA:

There are three Levels of exclusion criteria, each increasingly more stringent, based on the needs of the tasks being developed or populations being studied. For all studies, participants with mood or psychotic disorders will be stable and in treatment (i.e., no medication changes in the previous two weeks and a clearly identified treating psychiatrist). Minors with mood or psychotic disorders will not be included unless explicitly approved by the IRB for a particular task.

LEVEL 1 (Pilot study- does not require MRI. Task requires only feasibility testing on the bench.)

  1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment.
  2. Current use of psychoactive medications (unless required by the clinical diagnosis for which the task is being developed).

LEVEL 2 (Pilot study- does not require MRI. Task requires gathering of accurate behavioral data)

  1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment.
  2. Current use of psychoactive medications.
  3. Cognitive impairment.
  4. Current major mood, anxiety or psychotic disorder (unless task is being evaluated in a specific clinical population).

LEVEL 3 (Task requires MRI scanning)

  1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment.
  2. Current use of psychoactive medications (unless required by the clinical diagnosis for which the task is being developed).
  3. Cognitive impairment.
  4. Current major mood, anxiety or psychotic disorder (unless task is being evaluated in a specific clinical population)
  5. Pregnancy.
  6. Deep vein thrombosis:
  7. HIV positive individuals.
  8. Unable to undergo MRI scanning due to possible pregnancy, metallic devices in the body, claustrophobia or body morphometry.
  9. Currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.

ADDITIONAL EXCLUSION CRITERIA (EEG STUDIES):

1. Unable to avoid blinking for at least 2-3 sec when executing any task requiring EEG recording

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036685

Contacts
Contact: Elliot Stein, Ph.D. (443) 740-2650 estein@mail.nih.gov

Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC) Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254    researchstudies@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Elliot Stein, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01036685     History of Changes
Other Study ID Numbers: 999903379, 03-DA-N379
Study First Received: December 18, 2009
Last Updated: June 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Children
fMRI
Task Development
Cognition

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014