NCT01712633

Brief Summary

Background: \- Functional magnetic resonance imaging (fMRI) is used to study the brain. It takes a series of pictures that can be used to look at how the brain processes information. It is used to study problems with thinking, language, and movement, among other things. Researchers are working to develop new and better fMRI techniques. To test these techniques, they want to perform fMRI scans on healthy volunteers. Objectives: \- To test different fMRI techniques in healthy volunteers. Eligibility: \- Healthy volunteers at least 18 years of age. Design:

  • Participants will be screened with a physical exam and medical history.
  • Participants will have fMRI scans of the brain. During these scans, they will be asked to perform simple tasks. These tasks may involve language, thinking, or motor skills. The scanning sessions will last up to 2 hours.
  • Participants may be asked to return for additional fMRI scans over several years.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 19, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

2.6 years

First QC Date

October 20, 2012

Last Update Submit

November 19, 2021

Conditions

Keywords

fMRIBrain Perfusion

Outcome Measures

Primary Outcomes (1)

  • evaluation of fMRI techniques

    To test different fMRI techniques in healthy volunteers.

    Study day 1, followup visit(s)

Study Arms (1)

Volunteers

Healthy Volunteers

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers willing to come to NIH or are already part of an existing NIH protocol.

You may qualify if:

  • Healthy volunteers, new or from current NIH protocols are eligible. Healthy volunteers will be defined according the history obtained from reported medical history, medical record (reported at registration), the MRI safety questionnaire, and a clinical grade noncontrast brain MRI.
  • Willing to travel to the NIH for follow-up visits
  • Greater than 18 years old
  • Able to understand and sign informed consent.
  • Bilingual or multilingual subjects can participate in this study as long as the subjects are also fluent in English. Subjects do not need to be native or monolingual speakers of English.

You may not qualify if:

  • The following criteria will be used to exclude subjects from participating in this protocol:
  • Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples:
  • Aneurysm clip, implanted neural stimulator,
  • Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices,
  • Cochlear implant, ocular foreign body (metal shavings),
  • Any implanted device (pumps, infusion devices, etc.),
  • Shrapnel injuries,
  • History of metal in head or eyes or other parts of the body.
  • Vagus Nerve Stimulators (VNS)
  • Subjects with tattoos that contain metal.
  • Pregnant women
  • Over 350 lbs because of the weight limit of the MRI table
  • Prior surgery that may render performing the MRI to be unsafe.
  • Untreatable claustrophobia otherwise requiring anesthesia or antianxiety medications that may alter the subject s ability to perform the tasks during fMRI scanning.
  • Subjects will be asked to refrain from drinking or eating caffeinated foods or drinks the morning of the scan that can result in vessel vasoconstriction prior to the scan.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Hennig J, Speck O, Koch MA, Weiller C. Functional magnetic resonance imaging: a review of methodological aspects and clinical applications. J Magn Reson Imaging. 2003 Jul;18(1):1-15. doi: 10.1002/jmri.10330.

    PMID: 12815634BACKGROUND
  • Bennett CM, Miller MB. How reliable are the results from functional magnetic resonance imaging? Ann N Y Acad Sci. 2010 Mar;1191:133-55. doi: 10.1111/j.1749-6632.2010.05446.x.

    PMID: 20392279BACKGROUND
  • Pillai JJ. The evolution of clinical functional imaging during the past 2 decades and its current impact on neurosurgical planning. AJNR Am J Neuroradiol. 2010 Feb;31(2):219-25. doi: 10.3174/ajnr.A1845.

    PMID: 20150316BACKGROUND

Related Links

Study Officials

  • Nadia M Biassou, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2012

First Posted

October 23, 2012

Study Start

March 19, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

November 22, 2021

Record last verified: 2021-11

Locations