NCT01493804

Brief Summary

Background: \- Different regions of the brain are activated when a person performs a task. Electroencephalograms (EEGs) and near-infrared spectroscopy (NIRS) are tests that detect changes in the brain. EEG looks at changes in electrical signals, and NIRS looks at changes in blood flow. These tests can detect local changes in brain activity in a safe and noninvasive way. Researchers want to study brain activity more closely by combining these tests. Objectives: \- To use EEG and NIRS to study brain activity during specific tasks. Eligibility: \- Healthy volunteers at least 18 years of age. Design:

  • Participants will be screened with a physical exam and medical history.
  • Participants will have between one and five testing sessions. Each session will be 1 to 2 hours long. The tests given at each session will be determined by the researchers.
  • Participants will have EEG and NIRS tests, given either separately or together. During these tests, participants will perform tasks of thinking and reasoning.
  • Participants may also complete optional tests of thinking and reasoning. These tests will be given on paper or on a computer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

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

November 8, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

First QC Date

December 15, 2011

Last Update Submit

September 2, 2017

Conditions

Keywords

Near Infrared SpectroscopyEEGBrain ConnectivityHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or greater.

You may not qualify if:

  • Healthy volunteers with any skin disease.
  • Past or present hematologic abnormality of Hgb \< 9.0 gm/dl.
  • Healthy volunteers with any past or present vascular disease.
  • Have a history of substance abuse, psychiatric, or neurological disorders
  • Unable or unwilling to give informed consent.

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)

  • Akgul CB, Akin A, Sankur B. Extraction of cognitive activity-related waveforms from functional near-infrared spectroscopy signals. Med Biol Eng Comput. 2006 Nov;44(11):945-58. doi: 10.1007/s11517-006-0116-3. Epub 2006 Oct 24.

    PMID: 17061116BACKGROUND
  • Aydore S, Mihcak MK, Ciftci K, Akin A. On temporal connectivity of PFC via Gauss-Markov modeling of fNIRS signals. IEEE Trans Biomed Eng. 2010 Mar;57(3):761-8. doi: 10.1109/TBME.2009.2020792. Epub 2009 Apr 28.

    PMID: 19403360BACKGROUND
  • Badre D, Wagner AD. Selection, integration, and conflict monitoring; assessing the nature and generality of prefrontal cognitive control mechanisms. Neuron. 2004 Feb 5;41(3):473-87. doi: 10.1016/s0896-6273(03)00851-1.

    PMID: 14766185BACKGROUND

Study Officials

  • Amir Gandjbakhche, Ph.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 16, 2011

Study Start

November 8, 2011

Study Completion

September 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09-01

Locations