Focal Brain LesionNCT01087281
Top-Down Attentional Control of Visual-Processing
An observational study of Focal Brain Lesion and Focal Lesions, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Brain Lesion, Focal Lesions, fMRI
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2012to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers 18 years of age or older who are neurologically normal and in good general health. Patients 18 years of age or older with unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.
Who may be able to join
- All Subjects
- All subjects will be 18 years of age or older and have at least a high school education.
- Capacity to provide their own informed consent, understand and cooperate with study procedures.
- Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.
- Patients:
- Unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.
Show all 9Show fewer
- At least three months post-stroke, lobectomy and or neurosurgical resection.
- Healthy volunteers:
- 1. Neurologically normal and in good general health.
Who cannot join
- Patients:
- Any neurological or psychiatric disorder not related to the focal lesion (e.g., epilepsy, schizophrenia, etc.). Epilepsy patients who have undergone surgery and as a result are seizure free may be recruited.
- Previous head injury.
- Present or past (within past 6 months) drug or alcohol abuse or addiction as determined by a qualified study neurologist/psychiatrist.
- Radiation treatment to the brain during a three-month period prior to the experiment.
- Healthy volunteers:
Show all 25Show fewer
- Any neurological or psychiatric disorder (e.g., epilepsy, schizophrenia, etc.)
- Previous head injury.
- Present or past (within past 6 months) drug or alcohol abuse or addiction based on DSM-5 criteria as determined during History and Physical exam.
- ADDITIONAL EXCLUSION CRITERIA FOR MRI SCAN:
- Patients and Healthy volunteers:
- Women who are pregnant and women of child-bearing potential who refuse to undergo a urine pregnancy test will be excluded from fMRI experiments.
- Subjects who have contraindications to MRI scanning will be excluded from fMRI experiments but included in cognitive experiments. These contraindications include:
- central nervous system aneurysm clips;
- implanted neural stimulator;
- implanted cardiac pacemaker or defibrillator;
- cochlear implant;
- ocular foreign body (e.g., metal shavings);
- insulin pump;
- metal shrapnel or bullet;
- any implanted device that is incompatible with MRI.
- Conditions that preclude scanning, e.g., morbid obesity, claustrophobia.
- ADDITIONAL EXCLUSION CRITERIA FOR TASKS INVOLVING COLOR DISCRIMINATION:
- Patients and Healthy volunteers:
- Subjects who are determined during screening or history and physical exam to be color-blind will be excluded from participating in certain tasks that involve color discrimination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.
Read more
Objectives:
- To better understand the areas of the brain involved in paying attention to things that are seen.
Eligibility:
- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.
Design:
- The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours.
- Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit.
- On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests.
- Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors.
- Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity.
- During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.
Read the detailed description
Attention is required for most, if not all, perceptual processes. There is a converging body of evidence from single-cell recording studies in monkeys and neuroimaging, behavioral, and clinical studies in humans showing that the processing of attended information is enhanced relative to the processing of unattended information.
What is the source of this attentional modulation? Because neuroimaging studies have demonstrated that multiple cortical regions are recruited during tasks involving selective attention, it has proven difficult thus far to determine the differential contributions of each region. A central goal of the proposed research is to characterize the contributions of prefrontal cortex and parietal cortex and test the hypothesis that these regions exert top-down modulatory influences over visual processing areas. Specifically, we wish to investigate the interaction between areas involved in attentional control and visual areas modulated by attention.
We propose to study patients with focal lesions and healthy volunteers while they perform tasks requiring attention. Subjects will participate, first, in a series of behavioral studies involving selective attention; the relative performance of different patient groups and neurologically healthy volunteers will be compared. Subjects will also be studied while performing similar tasks during functional magnetic resonance imaging (fMRI). We hypothesize that selective attention will be heavily impaired by lesions of key prefrontal (e.g., dorsolateral prefrontal cortex) and key parietal (e.g., superior parietal lobule) sites. We also expect that brain imaging data will show decreased activation in visual regions ipsilateral to the focal lesions in prefrontal and parietal cortex, thus providing evidence that prefrontal and parietal cortex are sources of top-down modulation. Although other research groups have compared the behavior of patients with various focal lesions or have performed fMRI studies of visual attention in neurologically normal patients, we are unaware of any concerted effort to perform fMRI in patients with focal lesions in order to functionally isolate the contributions of individual cortical regions that serve as critical nodes in the attentional network.
- Conditions
- Focal Brain Lesion, Focal Lesions, fMRI
- Keywords
- Visual Attention, Visual Cortex, Focal Lesions, Neurological Disorder, Functional Magnetic Resonance Imaging (fMRI), Natural History, Focal Brain Lesion, Healthy Volunteer, HV
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Neurologically normal healthy volunteers in good general health. | |
| 2 | Patients with unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI signal across the whole brain during the MRI scans
The MRI signal varies with cortical area and with the stimuli and tasks performed by the subjects.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study start23 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Focal Brain LesionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shruti A Japee, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087281
- Sponsor's protocol ID
- 100047
- Other IDs
- 10-M-0047
- Status last verified
- 18 Aug 2026
- First submitted
- 13 Mar 2010
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The protocol team has not had the opportunity to discuss whether or not IPD data will be shared.
Publications
Bandettini PA, Wong EC, Hinks RS, Tikofsky RS, Hyde JS. Time course EPI of human brain function during task activation. Magn Reson Med. 1992 Jun;25(2):390-7. doi: 10.1002/mrm.1910250220.
PubMed 1614324Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
PubMed 1948051Fox PT, Raichle ME, Mintun MA, Dence C. Nonoxidative glucose consumption during focal physiologic neural activity. Science. 1988 Jul 22;241(4864):462-4. doi: 10.1126/science.3260686.
PubMed 3260686Gilmore AW, Audrain S, Snow J, Gollomp E, Wilson JM, Agron AM, Hammoud DA, Butman JA, Martin A. Long-term retention of real-world experiences in a patient with profound amnesia. Neuropsychologia. 2024 Nov 5;204:109010. doi: 10.1016/j.neuropsychologia.2024.109010. Epub 2024 Oct 9.
PubMed 39389294Zhang H, Japee S, Nolan R, Chu C, Liu N, Ungerleider LG. Face-selective regions differ in their ability to classify facial expressions. Neuroimage. 2016 Apr 15;130:77-90. doi: 10.1016/j.neuroimage.2016.01.045. Epub 2016 Jan 28.
PubMed 26826513Hansen KA, Chu C, Dickinson A, Pye B, Weller JP, Ungerleider LG. Spatial selectivity in the temporoparietal junction, inferior frontal sulcus, and inferior parietal lobule. J Vis. 2015;15(13):15. doi: 10.1167/15.13.15.
PubMed 26382006
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Top-Down Attentional Control of Visual-Processing
- ClinicalTrials.gov ID
- NCT01087281
- Acronym / sponsor ID
- 100047
- Conditions
- Focal Brain Lesion, Focal Lesions, fMRI
- Keywords
- Visual Attention, Visual Cortex, Focal Lesions, Neurological Disorder, Functional Magnetic Resonance Imaging (fMRI), Natural History, Focal Brain Lesion, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 23 Jul 2012 (actual)
- First posted
- 16 Mar 2010 (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:
- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.
Objectives:
- To better understand the areas of the brain involved in paying attention to things that are seen.
Eligibility:
- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.
Design:
- The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours.
- Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit.
- On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests.
- Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors.
- Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity.
- During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.
Detailed description
Attention is required for most, if not all, perceptual processes. There is a converging body of evidence from single-cell recording studies in monkeys and neuroimaging, behavioral, and clinical studies in humans showing that the processing of attended information is enhanced relative to the processing of unattended information.
What is the source of this attentional modulation? Because neuroimaging studies have demonstrated that multiple cortical regions are recruited during tasks involving selective attention, it has proven difficult thus far to determine the differential contributions of each region. A central goal of the proposed research is to characterize the contributions of prefrontal cortex and parietal cortex and test the hypothesis that these regions exert top-down modulatory influences over visual processing areas. Specifically, we wish to investigate the interaction between areas involved in attentional control and visual areas modulated by attention.
We propose to study patients with focal lesions and healthy volunteers while they perform tasks requiring attention. Subjects will participate, first, in a series of behavioral studies involving selective attention; the relative performance of different patient groups and neurologically healthy volunteers will be compared. Subjects will also be studied while performing similar tasks during functional magnetic resonance imaging (fMRI). We hypothesize that selective attention will be heavily impaired by lesions of key prefrontal (e.g., dorsolateral prefrontal cortex) and key parietal (e.g., superior parietal lobule) sites. We also expect that brain imaging data will show decreased activation in visual regions ipsilateral to the focal lesions in prefrontal and parietal cortex, thus providing evidence that prefrontal and parietal cortex are sources of top-down modulation. Although other research groups have compared the behavior of patients with various focal lesions or have performed fMRI studies of visual attention in neurologically normal patients, we are unaware of any concerted effort to perform fMRI in patients with focal lesions in order to functionally isolate the contributions of individual cortical regions that serve as critical nodes in the attentional network.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Neurologically normal healthy volunteers in good general health. |
| 2 | – | –Patients with unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers 18 years of age or older who are neurologically normal and in good general health. Patients 18 years of age or older with unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.
Key inclusion criteria (9 listed)
- All Subjects
- All subjects will be 18 years of age or older and have at least a high school education.
- Capacity to provide their own informed consent, understand and cooperate with study procedures.
- Able to read and write in English to guarantee understanding of all written and spoken instructions, which are in English.
- Unilateral or bilateral focal lesions of prefrontal, parietal, occipital or temporal cortex, or amygdala.
Key exclusion criteria (25 listed)
- Any neurological or psychiatric disorder not related to the focal lesion (e.g., epilepsy, schizophrenia, etc.). Epilepsy patients who have undergone surgery and as a result are seizure free may be recruited.
- Previous head injury.
- Present or past (within past 6 months) drug or alcohol abuse or addiction as determined by a qualified study neurologist/psychiatrist.
- Radiation treatment to the brain during a three-month period prior to the experiment.
- Any neurological or psychiatric disorder (e.g., epilepsy, schizophrenia, etc.)
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
MRI signal across the whole brain during the MRI scans
Time frame: Ongoing
The MRI signal varies with cortical area and with the stimuli and tasks performed by the subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 1614324Bandettini PA, Wong EC, Hinks RS, Tikofsky RS, Hyde JS. Time course EPI of human brain function during task activation. Magn Reson Med. 1992 Jun;25(2):390-7. doi: 10.1002/mrm.1910250220.
- Background: PubMed 1948051Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.
- Background: PubMed 3260686Fox PT, Raichle ME, Mintun MA, Dence C. Nonoxidative glucose consumption during focal physiologic neural activity. Science. 1988 Jul 22;241(4864):462-4. doi: 10.1126/science.3260686.
- Derived from this study: PubMed 39389294Gilmore AW, Audrain S, Snow J, Gollomp E, Wilson JM, Agron AM, Hammoud DA, Butman JA, Martin A. Long-term retention of real-world experiences in a patient with profound amnesia. Neuropsychologia. 2024 Nov 5;204:109010. doi: 10.1016/j.neuropsychologia.2024.109010. Epub 2024 Oct 9.
- Derived from this study: PubMed 26826513Zhang H, Japee S, Nolan R, Chu C, Liu N, Ungerleider LG. Face-selective regions differ in their ability to classify facial expressions. Neuroimage. 2016 Apr 15;130:77-90. doi: 10.1016/j.neuroimage.2016.01.045. Epub 2016 Jan 28.
- Derived from this study: PubMed 26382006Hansen KA, Chu C, Dickinson A, Pye B, Weller JP, Ungerleider LG. Spatial selectivity in the temporoparietal junction, inferior frontal sulcus, and inferior parietal lobule. J Vis. 2015;15(13):15. doi: 10.1167/15.13.15.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The protocol team has not had the opportunity to discuss whether or not IPD data will be shared.
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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.
Shruti A Japee, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
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 Focal Brain Lesion and Focal Lesions, run by National Institute of Mental Health (NIMH) 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 9 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NIMH LBC Volunteer ((301) 827-5157, nimhlbcvolunteer@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI signal across the whole brain during the MRI scans (time frame: Ongoing). 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 NCT01087281, which also lists 6 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 24 Aug 2026.