Healthy VolunteersNCT01493804
Noninvasive Study of Brain Connectivity With EEG and NIRS
An observational study of Healthy Volunteers, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2011to 1 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Non-Invasive Study of Brain Connectivity Using Combined EEG and NIRS
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Keywords
- Near Infrared Spectroscopy, EEG, Brain Connectivity, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study start8 Nov 2011
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amir Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493804
- Sponsor's protocol ID
- 120011
- Other IDs
- 12-CH-0011
- Status last verified
- 1 Sep 2017
- First submitted
- 15 Dec 2011
- Last updated
- 6 Sep 2017
- Results posted
- No
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 17061116Aydore 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 19403360Badre 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Study of Brain Connectivity Using Combined EEG and NIRS
- ClinicalTrials.gov ID
- NCT01493804
- Acronym / sponsor ID
- 120011
- Conditions
- Healthy Volunteers
- Keywords
- Near Infrared Spectroscopy, EEG, Brain Connectivity, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 8 Nov 2011
- Study completion
- 1 Sep 2017
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or greater.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Background: PubMed 17061116Akgul 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.
- Background: PubMed 19403360Aydore 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.
- Background: PubMed 14766185Badre 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01493804, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.