Healthy VolunteersNCT01974427
Functional Brain Imaging in Healthy Volunteers to Study Cognitive Functions
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Objective: The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2013to 20 Jun 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A subject can be included if he/she:
- is in good general health;
- is between 18 and 65 years old;
- is capable of understanding the procedures and requirements of this study;
- is willing and able to provide his/her own informed consent.
Who cannot join
- A subject will be excluded if he/she:
- has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); insulin pump as per the NMR Safety Screening Form.
- underwent brain surgery, who have a central nervous system illness, neurological lesion, a psychiatric history or recurrent migraines that require medication will also be excluded from this study: Healthy volunteer form.
- has uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease.
- has metal in the cranial cavity and/or holes in the skull made by trauma or surgery.
- cannot lie comfortably flat on their back for up to 180 minutes in the MRI scanner
Show all 9Show fewer
- has claustrophobia
- Subjects may participate in this study, but will not be allowed to have a 7T MRI scan if they have metallic dental crowns or a bridge.
- Subjects may participate in the study, but will not have tDCS if they have broken skin or a wound in the area where electrodes will be placed.
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
Objective:
The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. This research is expected to help develop techniques and hypotheses for future research on these topics.
Read more
We will conduct:
- Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be acquisition of sufficient information to generate a power analysis. There are no enrollment limitations for pilot substudies.
- Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be tested that can be completed with a few healthy volunteers or patients. Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects (if there is one group) or after 12 (6 per arm) if two groups are studied before additional subjects are recruited. In the event of subject dropout or unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis substudy with more subjects without an amendment or whether an amendment or new protocol would be necessary. A memo requesting a review of hypothesis-testing substudies for possible additional enrollment will be sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB.
- Technical development of new experimental paradigms and data analysis methods.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG, tDCS).
Study Population:
We plan to recruit up to 120 healthy volunteers aged 18-65.
Design:
We will design small projects that are pertinent to the theme of scale-free brain activity and conscious/unconscious processing. We will investigate healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
In the substudies, brain activity of healthy human volunteers will be monitored by functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS) is ideally suited to modulate the slow component of scale-free brain activity, we will also investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive tasks. In some experiments, we will study resting-state brain function, during which spontaneous brain activity is collected without a specific externally administered task.
Outcome Measures:
MRI: to analyze measures such as the anatomical structures of the brain (using structural MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)].
EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.
Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography (EMG) patterns.
We may measure autonomic data during the course of the experiment (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome measures.
Read the detailed description
Objective:
The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. This research is expected to help develop techniques and hypotheses for future research on these topics.
We will conduct:
- Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be acquisition of sufficient information to generate a power analysis. There are no enrollment limitations for pilot substudies.
- Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be tested that can be completed with a few healthy volunteers or patients. Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects (if there is one group) or after 12 (6 per arm) if two groups are studied before additional subjects are recruited. In the event of subject dropout or unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis substudy with more subjects without an amendment or whether an amendment or new protocol would be necessary. A memo requesting a review of hypothesis-testing substudies for possible additional enrollment will be sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB.
- Technical development of new experimental paradigms and data analysis methods.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG, tDCS).
Study Population:
We plan to recruit up to 200 healthy volunteers aged 18-65.
Design:
We will design small projects that are pertinent to the theme of scale-free brain activity and conscious/unconscious processing. We will investigate healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
In the substudies, brain activity of healthy human volunteers will be monitored by functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS) is ideally suited to modulate the slow component of scale-free brain activity, we will also investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive tasks. In some experiments, we will study resting-state brain function, during which spontaneous brain activity is collected without a specific externally administered task.
Outcome Measures:
MRI: to analyze measures such as the anatomical structures of the brain (using structural MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)].
EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.
Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography (EMG) patterns.
We may measure autonomic data during the course of the experiment (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome measures.
- Conditions
- Healthy Volunteers
- Keywords
- Magnetic Resonance Imaging (MRI), Functional Imaging, BOLD Effect, EEG, MEG
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measures, brain activity recorded by MRI, EEG, MEG, as well as changes in the above measures induced by tDCS
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study start26 Oct 2013
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Alan P. Koretsky, Ph.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974427
- Sponsor's protocol ID
- 140002
- Other IDs
- 14-N-0002
- Status last verified
- 29 May 2019
- First submitted
- 26 Oct 2013
- Last updated
- 31 May 2019
- Results posted
- No
Publications
He BJ, Zempel JM, Snyder AZ, Raichle ME. The temporal structures and functional significance of scale-free brain activity. Neuron. 2010 May 13;66(3):353-69. doi: 10.1016/j.neuron.2010.04.020.
PubMed 20471349He BJ. Scale-free properties of the functional magnetic resonance imaging signal during rest and task. J Neurosci. 2011 Sep 28;31(39):13786-95. doi: 10.1523/JNEUROSCI.2111-11.2011.
PubMed 21957241Ray S, Maunsell JH. Different origins of gamma rhythm and high-gamma activity in macaque visual cortex. PLoS Biol. 2011 Apr;9(4):e1000610. doi: 10.1371/journal.pbio.1000610. Epub 2011 Apr 12.
PubMed 21532743
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Imaging in Healthy Volunteers to Study Cognitive Functions
- ClinicalTrials.gov ID
- NCT01974427
- Acronym / sponsor ID
- 140002
- Conditions
- Healthy Volunteers
- Keywords
- Magnetic Resonance Imaging (MRI), Functional Imaging, BOLD Effect, EEG, MEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Oct 2013
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 1 Nov 2013 (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.
Objective:
The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. This research is expected to help develop techniques and hypotheses for future research on these topics.
We will conduct:
- Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be acquisition of sufficient information to generate a power analysis. There are no enrollment limitations for pilot substudies.
- Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be tested that can be completed with a few healthy volunteers or patients. Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects (if there is one group) or after 12 (6 per arm) if two groups are studied before additional subjects are recruited. In the event of subject dropout or unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis substudy with more subjects without an amendment or whether an amendment or new protocol would be necessary. A memo requesting a review of hypothesis-testing substudies for possible additional enrollment will be sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB.
- Technical development of new experimental paradigms and data analysis methods.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG, tDCS).
Study Population:
We plan to recruit up to 120 healthy volunteers aged 18-65.
Design:
We will design small projects that are pertinent to the theme of scale-free brain activity and conscious/unconscious processing. We will investigate healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
In the substudies, brain activity of healthy human volunteers will be monitored by functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS) is ideally suited to modulate the slow component of scale-free brain activity, we will also investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive tasks. In some experiments, we will study resting-state brain function, during which spontaneous brain activity is collected without a specific externally administered task.
Outcome Measures:
MRI: to analyze measures such as the anatomical structures of the brain (using structural MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)].
EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.
Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography (EMG) patterns.
We may measure autonomic data during the course of the experiment (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome measures.
Detailed description
Objective:
The goal of this protocol is to improve understanding scale-free brain activity and conscious vs. unconscious processing by performing small behavioral, electrophysiological, neuroimaging and brain stimulation pilot substudies. This research is expected to help develop techniques and hypotheses for future research on these topics.
We will conduct:
- Pilot Substudy: Pilot substudies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be acquisition of sufficient information to generate a power analysis. There are no enrollment limitations for pilot substudies.
- Hypothesis-Testing Substudy is defined as a study with a specific hypothesis to be tested that can be completed with a few healthy volunteers or patients. Hypothesis-testing substudies will undergo statistical and PIRC reviews after 6 subjects (if there is one group) or after 12 (6 per arm) if two groups are studied before additional subjects are recruited. In the event of subject dropout or unsuccessful recording, replacement will be recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis substudy with more subjects without an amendment or whether an amendment or new protocol would be necessary. A memo requesting a review of hypothesis-testing substudies for possible additional enrollment will be sent to PIRC and the statistical reviewer. The memo will be forwarded to the CNS IRB.
- Technical development of new experimental paradigms and data analysis methods.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, EMG, tDCS).
Study Population:
We plan to recruit up to 200 healthy volunteers aged 18-65.
Design:
We will design small projects that are pertinent to the theme of scale-free brain activity and conscious/unconscious processing. We will investigate healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a hypothesis testing substudy leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
In the substudies, brain activity of healthy human volunteers will be monitored by functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG), electroencephalography (EEG), or simultaneous MEG-EEG. Anatomical MRI will be collected in some subjects to allow better localization of brain dynamics. Because transcranial direct-current stimulation (tDCS) is ideally suited to modulate the slow component of scale-free brain activity, we will also investigate the effect of tDCS on brain activity and/or behavioral performance in cognitive tasks. tDCS will be administered sequentially, but not simultaneously, with brain-activity monitoring by fMRI/MEG/EEG. Most experiments will be conducted in conjunction with cognitive tasks. In some experiments, we will study resting-state brain function, during which spontaneous brain activity is collected without a specific externally administered task.
Outcome Measures:
MRI: to analyze measures such as the anatomical structures of the brain (using structural MRI); amplitude of the blood-oxygenation-level-dependent (BOLD) signal (using fMRI); cerebral blood flow [using arterial spin labeling (ASL)] and different neurotransmitter levels in brain regions of interest [using magnetic resonance spectroscopy (MRS)].
EEG and MEG: to quantify measures such as power spectrum, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
tDCS: to analyze changes in behavioral measures and/or fMRI/EEG/MEG activity caused by tDCS.
Behavioral measures: to quantify measures such as hit rate, reaction times, electromyography (EMG) patterns.
We may measure autonomic data during the course of the experiment (such as heart rate, respiration, end-tidal CO2, skin conductance), which will be correlated with the outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- is in good general health;
- is between 18 and 65 years old;
- is capable of understanding the procedures and requirements of this study;
- is willing and able to provide his/her own informed consent.
Key exclusion criteria (9 listed)
- has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings); insulin pump as per the NMR Safety Screening Form.
- underwent brain surgery, who have a central nervous system illness, neurological lesion, a psychiatric history or recurrent migraines that require medication will also be excluded from this study: Healthy volunteer form.
- has uncontrolled medical problems, such as diabetes mellitus, hypertension, pulmonary or airway disease, heart failure, coronary artery disease.
- has metal in the cranial cavity and/or holes in the skull made by trauma or surgery.
- cannot lie comfortably flat on their back for up to 180 minutes in the MRI scanner
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
Behavioral measures, brain activity recorded by MRI, EEG, MEG, as well as changes in the above measures induced by tDCS
Time frame: 10 years
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 31 May 2019.
- Background: PubMed 20471349He BJ, Zempel JM, Snyder AZ, Raichle ME. The temporal structures and functional significance of scale-free brain activity. Neuron. 2010 May 13;66(3):353-69. doi: 10.1016/j.neuron.2010.04.020.
- Background: PubMed 21957241He BJ. Scale-free properties of the functional magnetic resonance imaging signal during rest and task. J Neurosci. 2011 Sep 28;31(39):13786-95. doi: 10.1523/JNEUROSCI.2111-11.2011.
- Background: PubMed 21532743Ray S, Maunsell JH. Different origins of gamma rhythm and high-gamma activity in macaque visual cortex. PLoS Biol. 2011 Apr;9(4):e1000610. doi: 10.1371/journal.pbio.1000610. Epub 2011 Apr 12.
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Irritability
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.
Alan P. Koretsky, Ph.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 National Institute of Neurological Disorders and Stroke (NINDS) 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 5 inclusion and 9 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 31 May 2019. 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.
What does the primary outcome measure?
Behavioral measures, brain activity recorded by MRI, EEG, MEG, as well as changes in the above measures induced by tDCS (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974427, 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 31 May 2019.