Healthy VolunteersNCT00728741
Brain Activity During Strategic Planning
An observational study of Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will locate areas in the brain that help people devise action plans to carry out complex tasks requiring use of strategy. The ability to plan strategically is impaired in patients who have had a stroke affecting the front parts of the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2008to 26 May 2010
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects from ages 18 to 60
- Subjects must be right-hand dominant as defined by the Edinburgh Handedness inventory: (R. C. Oldfield, 1971) -Right lateralized handedness quotient of greater than 0.75 will be considered R handed)
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the FMRI scanning.
Who cannot join
- Subjects with clinically significant abnormal findings on neurological exam in any of the following neurological domains: cognitive, cranial nerve, motor, sensory, cerebellar functions.
- Subjects who are pregnant (as determined by positive urine pregnancy test)
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects with metallic dental fillings which are likely to cause MRI artifacts
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from lying flat for up to 120 minutes
- Subjects without the capacity to give informed consent
- Subjects with claustrophobia or other restrictions which prevent them from undergoing a scan in a confined space for up to 60 minutes
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: Functional Neuro-Imaging of Strategy Use During Human Behavior
This study will locate areas in the brain that help people devise action plans to carry out complex tasks requiring use of strategy. The ability to plan strategically is impaired in patients who have had a stroke affecting the front parts of the brain. This study will use functional magnetic resonance imaging (fMRI) to examine the activity of different areas of the brain during the formulation and execution of plans.
Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH Clinical Center four to five times to complete the following procedures:
Read more
Visit 1 - Screening
- Medical history
- Physical and neurological examinations
Visit 2 - MRI brain scan (if one has not been done within the past year)
MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning.
Visits 3 to 5 - Task training sessions and two fMRI scans
Functional MRI involves taking MRI scans while the subject performs a task in order to learn about changes in brain regions that are involved in the performance of the task. Subjects are trained in two tasks (see below) and then perform the tasks while in the MRI scanner.
- Task 1: The subject presses computer keys in response to the direction of arrows shown on the computer screen. The keys are pressed according to a given set of rules the subject is taught.
- Task 2: This task is similar to task 1, but the subject is also asked to remember certain previous actions and responses.
Read the detailed description
OBJECTIVES
Efficient behavior requires the ability to generalize from previous experiences. This can be achieved by behavioral strategies. We use many behavioral strategies; some strategies have strict S-R associations -stop at the RED light-; others are modifiable -balancing skills of a ballerina that becomes very useful during rock climbing- and serve as abstract strategies that enable solving problems.
Strategy use is common in our behavioral repertoire. A strategy can be defined as a set of computations associated with the act of planning and directing overall operations and movements involved in a task. A behavioral strategy that conscious behaving primates spontaneously adopted in order to maximize their rewards have been well characterized in the literature. These are called "Repeat-Stay"/"Change-Shift" strategy, and were shown to be associated with prefrontal neuronal activity during multi-unit intra-cortical recordings, clearly indicating a special role played by the prefrontal cortex in computing strategy use. It is important to understand how the human brain computes and processes strategies. This study aims at understanding the activation patterns, and neuronal connectivity in the human brain when engaged in tasks that require strategies. We hypothesize that application of strategies to solve tasks would show specifically and significantly increase Blood Oxygenation Dependant (BOLD) signal, particularly the fronto-polar cortex (PFp), ventral and orbitofrontal prefrontal cortex (PFV+o) in the human brains.
STUDY POPULATION
The two experiments described in this protocol may recruit up to 61 (6 for the pilot study) adult healthy volunteers.
DESIGN
The study will consist of functional Magnetic Resonance Imaging (fMRI). The fMRI will consist of two separate experiments: (1) the strategy experiment and (2) the memory control experiment. Data will be analyzed separately for each part of the experiment: Responses to tasks will be collected and this data (response times, accuracy rates) will be searched for statistically significant differences using linear contrasts in an ANOVA model.
The imaging fMRI data will be analyzed for statistically significant functional activations by using an implementation of the General Linear Model (GLM) (R. Turner et al., 1998; K. J. Friston et al., 2005) in Statistical Parametric Mapping (SPM).
OUTCOME MEASURES
We propose to acquire response data (response times, error rates), and functional brain activation data using fMRI. Therefore, we would have two outcome measures.
From the response data we will evaluate statistically significant differences in response times, error rates, learning curves.
From the BOLD fMRI data, the main outcome would be task specific neural activations that would regress with the behavioral tasks in a General Linear Model.
These measures will further our understanding about how the human brains use strategies during complex task performance. This will lay the foundation to our understanding for how we are capable of generalizing our experiences from specific instances. Such knowledge will also improve our understanding of various aspects of movement genesis, and is likely to eventually shed light on various movement disorders including psychogenic movement disorders and chorea among others.
- Conditions
- Healthy Volunteers
- Keywords
- Neural Networks, Cortical Activation, Strategy, fMRI, 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 posted6 Aug 2008 (estimated)
- Study start1 Aug 2008
- Study completion26 May 2010
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728741
- Sponsor's protocol ID
- 080192
- Other IDs
- 08-N-0192
- Status last verified
- 26 May 2010
- First submitted
- 5 Aug 2008
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Blakemore SJ, Goodbody SJ, Wolpert DM. Predicting the consequences of our own actions: the role of sensorimotor context estimation. J Neurosci. 1998 Sep 15;18(18):7511-8. doi: 10.1523/JNEUROSCI.18-18-07511.1998.
PubMed 9736669Bunge SA. How we use rules to select actions: a review of evidence from cognitive neuroscience. Cogn Affect Behav Neurosci. 2004 Dec;4(4):564-79. doi: 10.3758/cabn.4.4.564.
PubMed 15849898Bunge SA, Wright SB. Neurodevelopmental changes in working memory and cognitive control. Curr Opin Neurobiol. 2007 Apr;17(2):243-50. doi: 10.1016/j.conb.2007.02.005. Epub 2007 Feb 23.
PubMed 17321127
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuro-Imaging of Strategy Use During Human Behavior
- ClinicalTrials.gov ID
- NCT00728741
- Acronym / sponsor ID
- 080192
- Conditions
- Healthy Volunteers
- Keywords
- Neural Networks, Cortical Activation, Strategy, fMRI, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Aug 2008
- Study completion
- 26 May 2010
- First posted
- 6 Aug 2008 (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.
This study will locate areas in the brain that help people devise action plans to carry out complex tasks requiring use of strategy. The ability to plan strategically is impaired in patients who have had a stroke affecting the front parts of the brain. This study will use functional magnetic resonance imaging (fMRI) to examine the activity of different areas of the brain during the formulation and execution of plans.
Right-handed healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH Clinical Center four to five times to complete the following procedures:
Visit 1 - Screening
- Medical history
- Physical and neurological examinations
Visit 2 - MRI brain scan (if one has not been done within the past year)
MRI - This test uses a strong magnetic field and radio waves to obtain images of the brain. The scanner is a metal cylinder surrounded by a magnetic field. The subject lies on a table that can slide in and out of the scanner, wearing earplugs to muffle loud noises that occur during the scanning.
Visits 3 to 5 - Task training sessions and two fMRI scans
Functional MRI involves taking MRI scans while the subject performs a task in order to learn about changes in brain regions that are involved in the performance of the task. Subjects are trained in two tasks (see below) and then perform the tasks while in the MRI scanner.
- Task 1: The subject presses computer keys in response to the direction of arrows shown on the computer screen. The keys are pressed according to a given set of rules the subject is taught.
- Task 2: This task is similar to task 1, but the subject is also asked to remember certain previous actions and responses.
Detailed description
OBJECTIVES
Efficient behavior requires the ability to generalize from previous experiences. This can be achieved by behavioral strategies. We use many behavioral strategies; some strategies have strict S-R associations -stop at the RED light-; others are modifiable -balancing skills of a ballerina that becomes very useful during rock climbing- and serve as abstract strategies that enable solving problems.
Strategy use is common in our behavioral repertoire. A strategy can be defined as a set of computations associated with the act of planning and directing overall operations and movements involved in a task. A behavioral strategy that conscious behaving primates spontaneously adopted in order to maximize their rewards have been well characterized in the literature. These are called "Repeat-Stay"/"Change-Shift" strategy, and were shown to be associated with prefrontal neuronal activity during multi-unit intra-cortical recordings, clearly indicating a special role played by the prefrontal cortex in computing strategy use. It is important to understand how the human brain computes and processes strategies. This study aims at understanding the activation patterns, and neuronal connectivity in the human brain when engaged in tasks that require strategies. We hypothesize that application of strategies to solve tasks would show specifically and significantly increase Blood Oxygenation Dependant (BOLD) signal, particularly the fronto-polar cortex (PFp), ventral and orbitofrontal prefrontal cortex (PFV+o) in the human brains.
STUDY POPULATION
The two experiments described in this protocol may recruit up to 61 (6 for the pilot study) adult healthy volunteers.
DESIGN
The study will consist of functional Magnetic Resonance Imaging (fMRI). The fMRI will consist of two separate experiments: (1) the strategy experiment and (2) the memory control experiment. Data will be analyzed separately for each part of the experiment: Responses to tasks will be collected and this data (response times, accuracy rates) will be searched for statistically significant differences using linear contrasts in an ANOVA model.
The imaging fMRI data will be analyzed for statistically significant functional activations by using an implementation of the General Linear Model (GLM) (R. Turner et al., 1998; K. J. Friston et al., 2005) in Statistical Parametric Mapping (SPM).
OUTCOME MEASURES
We propose to acquire response data (response times, error rates), and functional brain activation data using fMRI. Therefore, we would have two outcome measures.
From the response data we will evaluate statistically significant differences in response times, error rates, learning curves.
From the BOLD fMRI data, the main outcome would be task specific neural activations that would regress with the behavioral tasks in a General Linear Model.
These measures will further our understanding about how the human brains use strategies during complex task performance. This will lay the foundation to our understanding for how we are capable of generalizing our experiences from specific instances. Such knowledge will also improve our understanding of various aspects of movement genesis, and is likely to eventually shed light on various movement disorders including psychogenic movement disorders and chorea among others.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects from ages 18 to 60
- Subjects must be right-hand dominant as defined by the Edinburgh Handedness inventory: (R. C. Oldfield, 1971) -Right lateralized handedness quotient of greater than 0.75 will be considered R handed)
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the FMRI scanning.
Key exclusion criteria (8 listed)
- Subjects with clinically significant abnormal findings on neurological exam in any of the following neurological domains: cognitive, cranial nerve, motor, sensory, cerebellar functions.
- Subjects who are pregnant (as determined by positive urine pregnancy test)
- Subjects with any finding on the MRI safety questionnaire which prevents them from safely undergoing an MRI scan
- Subjects with metallic dental fillings which are likely to cause MRI artifacts
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
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 2 Jul 2017.
- Background: PubMed 9736669Blakemore SJ, Goodbody SJ, Wolpert DM. Predicting the consequences of our own actions: the role of sensorimotor context estimation. J Neurosci. 1998 Sep 15;18(18):7511-8. doi: 10.1523/JNEUROSCI.18-18-07511.1998.
- Background: PubMed 15849898Bunge SA. How we use rules to select actions: a review of evidence from cognitive neuroscience. Cogn Affect Behav Neurosci. 2004 Dec;4(4):564-79. doi: 10.3758/cabn.4.4.564.
- Background: PubMed 17321127Bunge SA, Wright SB. Neurodevelopmental changes in working memory and cognitive control. Curr Opin Neurobiol. 2007 Apr;17(2):243-50. doi: 10.1016/j.conb.2007.02.005. Epub 2007 Feb 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 inclusion and 8 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 2 Jul 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 NCT00728741, 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 2 Jul 2017.