NCT00466934

Brief Summary

This study will test a method of measuring brain blood flow called near infrared spectroscopy (NIRS). It will determine whether NIRS gives the same results as the more commonly used technique, functional magnetic resonance imaging (fMRI). Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the following tasks while they are undergoing NIRS or fMRI:

  • looking at a computer monitor while a checkerboard pattern changes
  • wiggling the toes and moving the fingers
  • Reading words on a computer screen and pushing one button if they are plants and another if they are animals. For NIRS, a frame is placed on the head and held it in place with a metal band. The frame holds sensors that contact the scalp. For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio waves to obtain images of the brain while the subject performs tasks. During the procedure, The subject wears earplugs to muffle the sound of loud knocking noises that occur during scanning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 24, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2011

Completed
Last Updated

July 2, 2017

Status Verified

December 29, 2011

First QC Date

April 26, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Cerebral Blood FlowCerebral CortexCognitionOptical ImagingHealthy VolunteerHV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 60, inclusive.

You may not qualify if:

  • Pregnancy.
  • History of hypertension.
  • History of any disease of the central nervous system.
  • Current use of sedating medication, including antihistamines.
  • Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.

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)

  • Benaron DA, Hintz SR, Villringer A, Boas D, Kleinschmidt A, Frahm J, Hirth C, Obrig H, van Houten JC, Kermit EL, Cheong WF, Stevenson DK. Noninvasive functional imaging of human brain using light. J Cereb Blood Flow Metab. 2000 Mar;20(3):469-77. doi: 10.1097/00004647-200003000-00005.

    PMID: 10724111BACKGROUND
  • Biswal B, Hudetz AG, Yetkin FZ, Haughton VM, Hyde JS. Hypercapnia reversibly suppresses low-frequency fluctuations in the human motor cortex during rest using echo-planar MRI. J Cereb Blood Flow Metab. 1997 Mar;17(3):301-8. doi: 10.1097/00004647-199703000-00007.

    PMID: 9119903BACKGROUND
  • Biswal B, Yetkin FZ, Haughton VM, Hyde JS. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI. Magn Reson Med. 1995 Oct;34(4):537-41. doi: 10.1002/mrm.1910340409.

    PMID: 8524021BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

April 24, 2007

Study Completion

December 29, 2011

Last Updated

July 2, 2017

Record last verified: 2011-12-29

Locations