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Noninvasive Study of Brain Connectivity With EEG and NIRS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493804
First Posted: December 16, 2011
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
  Purpose

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.

Condition
Healthy Volunteers

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-Invasive Study of Brain Connectivity Using Combined EEG and NIRS

Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

Enrollment: 5
Study Start Date: November 8, 2011
Estimated Study Completion Date: September 1, 2017
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Age 18 years or greater.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493804


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Publications:
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01493804     History of Changes
Other Study ID Numbers: 120011
12-CH-0011
First Submitted: December 15, 2011
First Posted: December 16, 2011
Last Update Posted: September 6, 2017
Last Verified: September 1, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Near Infrared Spectroscopy
EEG
Brain Connectivity
Healthy Volunteer
HV