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CompletedNCT01493804Updated Sep 6, 2017

Noninvasive Study of Brain Connectivity With EEG and NIRS

An observational study in Healthy Volunteers, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-06.

Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

Objective: To record near-infrared optical signal (NIRS) simultaneously with EEG signal and correlate hemodynamic and neuronal responses, and to understand brain connectivity associated with cognitive functions using combined EEG/NIRS technology

Study population: 40 healthy volunteers

Design: The study will aim to capture the dynamics of brain interactions on two different scales by combing EEG (neuronal) and NIRS (hemodynamic) techniques. We will then correlate the two responses to study the brain connectivity in a more comprehensive way.

Outcome Measures: graded changes in blood flow and blood oxygenation, measured with NIRS, along with electrical signals recorded by EEG in response to different functional tasks.

Note: This study is sponsored by the Center for Neuroscience and Regenerative Medicine (CNRM). De-identified data including imaging data sent to CNRM may be shared with outside investigators or collaborators. This data may be used for a variety of research purposes. The Henry M. Jackson Foundation for the Advancement for Military Medicine (HJF), USUHS, or DOD representatives may also access data for audit purposes.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Near Infrared Spectroscopy
  • EEG
  • Brain Connectivity
  • Healthy Volunteer
  • HV
03

In context

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is the lead sponsor of 416 studies on the registry; 25 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 years or greater.

Exclusion criteria

EXCLUSION CRITERIA:

  • 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
  • Any medical condition that, in the opinion of the Principal Investigator, would preclude the inclusion of a patient onto this research study.
  • Unable or unwilling to give informed consent.
05

Study design

Time perspective
Prospective
Enrollment
5 participants (actual)
06

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
07

References and documents

Publications

  • 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. PubMed 17061116 ↗
  • 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. PubMed 19403360 ↗
  • 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. PubMed 14766185 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01493804
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Dec 16, 2011
Start date
Nov 8, 2011
Completion
Sep 1, 2017
Last update
Sep 6, 2017

Study contacts

Amir Gandjbakhche, Ph.D.
principal investigator · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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