SchizophreniaNCT01011101
Internal Monitoring of Eye Movement in Schizophrenia
An observational study of Schizophrenia, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Background: Researchers are studying how humans are able to move our eyes to a remembered region even when the target has disappeared. The ability to do this suggests that the brain can keep track of where the eyes have looked, without an external target for continued reference. This is called corollary discharge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2009to 16 Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects over 18 years of age who are able to give informed consent and are able to concentrate on a task for 20 minutes which involves following projected targets and moving their eyes to remembered locations.
Who cannot join
- Large refractive error requiring strong glasses. Glasses may interfere with the video eye movement recording system. However, participants may wear contact lenses. Subjects with a history of eye disease affecting vision or eye movements will also be excluded.
- Participants with guardians will be excluded.
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
Background:
- Researchers are studying how humans are able to move our eyes to a remembered region even when the target has disappeared. The ability to do this suggests that the brain can keep track of where the eyes have looked, without an external target for continued reference. This is called corollary discharge.
- Other research has indicated that patients with schizophrenia might have difficulty monitoring their eye movements. The corollary discharge process may be defective in patients with schizophrenia, and perhaps delayed in time. Researchers have developed a test to examine this possibility in the hope of learning more about schizophrenia and eye movement.
Read more
Objectives:
- To assess whether there is a defect in internal monitoring of eye movements in patients with schizophrenia.
Eligibility:
- Individuals over 18 years of age who are able to give informed consent and are able to concentrate on a 20-minute task that involves following projected targets and moving their eyes to remembered locations.
- Individuals with schizophrenia will be recruited from an ongoing NIH protocol studying schizophrenia.
- In addition healthy will be recruited for this protocol.
Design:
- Researchers will check participants' vision in each eye, and ask them to sit at a machine that measures eye movement in order to complete research tasks. Researchers will monitor participants ability to complete these tasks.
- The first task involves simply following a target that jumps to different parts of the screen.
- The second is a 2-step task, in which a participant is asked to look at two separate light targets and then look at the remembered target positions when the lights are off.
- This protocol does not provide treatment. Participants will remain under the care of their own physicians during participation in this protocol.
Read the detailed description
OBJECTIVE:
To study if there is a defect in internal monitoring of eye movements in patients with schizophrenia.
STUDY POPULATION:
Patients with schizophrenia and normal controls.
DESIGN:
Patients and controls will be asked to follow targets to remembered locations and their eye movements will be monitored.
OUTCOME MEASURES:
Eye movements will be examined for evidence of internal monitoring (corollary discharge) defects which would result in mislocalizing remembered targets.
- Conditions
- Schizophrenia
- Keywords
- Saccadic Eye Movements, Schizophrenia, Healthy Volunteer, HV
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of recordings between groups
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study start2 Nov 2009
- Study completion16 Aug 2016
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 SchizophreniaStudies 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
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Edmond J FitzGibbon, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011101
- Sponsor's protocol ID
- 100016
- Other IDs
- 10-EI-0016
- Status last verified
- 16 Aug 2016
- First submitted
- 10 Nov 2009
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Andreasen NC, Nopoulos P, O'Leary DS, Miller DD, Wassink T, Flaum M. Defining the phenotype of schizophrenia: cognitive dysmetria and its neural mechanisms. Biol Psychiatry. 1999 Oct 1;46(7):908-20. doi: 10.1016/s0006-3223(99)00152-3.
PubMed 10509174Campanella S, Guerit JM. How clinical neurophysiology may contribute to the understanding of a psychiatric disease such as schizophrenia. Neurophysiol Clin. 2009 Feb;39(1):31-9. doi: 10.1016/j.neucli.2008.12.002. Epub 2009 Jan 9.
PubMed 19268845Duhamel JR, Goldberg ME, Fitzgibbon EJ, Sirigu A, Grafman J. Saccadic dysmetria in a patient with a right frontoparietal lesion. The importance of corollary discharge for accurate spatial behaviour. Brain. 1992 Oct;115 ( Pt 5):1387-402. doi: 10.1093/brain/115.5.1387.
PubMed 1422794
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Monitoring of Eye Movement in Schizophrenia
- ClinicalTrials.gov ID
- NCT01011101
- Acronym / sponsor ID
- 100016
- Conditions
- Schizophrenia
- Keywords
- Saccadic Eye Movements, Schizophrenia, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 2 Nov 2009
- Study completion
- 16 Aug 2016
- First posted
- 11 Nov 2009 (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:
- Researchers are studying how humans are able to move our eyes to a remembered region even when the target has disappeared. The ability to do this suggests that the brain can keep track of where the eyes have looked, without an external target for continued reference. This is called corollary discharge.
- Other research has indicated that patients with schizophrenia might have difficulty monitoring their eye movements. The corollary discharge process may be defective in patients with schizophrenia, and perhaps delayed in time. Researchers have developed a test to examine this possibility in the hope of learning more about schizophrenia and eye movement.
Objectives:
- To assess whether there is a defect in internal monitoring of eye movements in patients with schizophrenia.
Eligibility:
- Individuals over 18 years of age who are able to give informed consent and are able to concentrate on a 20-minute task that involves following projected targets and moving their eyes to remembered locations.
- Individuals with schizophrenia will be recruited from an ongoing NIH protocol studying schizophrenia.
- In addition healthy will be recruited for this protocol.
Design:
- Researchers will check participants' vision in each eye, and ask them to sit at a machine that measures eye movement in order to complete research tasks. Researchers will monitor participants ability to complete these tasks.
- The first task involves simply following a target that jumps to different parts of the screen.
- The second is a 2-step task, in which a participant is asked to look at two separate light targets and then look at the remembered target positions when the lights are off.
- This protocol does not provide treatment. Participants will remain under the care of their own physicians during participation in this protocol.
Detailed description
OBJECTIVE:
To study if there is a defect in internal monitoring of eye movements in patients with schizophrenia.
STUDY POPULATION:
Patients with schizophrenia and normal controls.
DESIGN:
Patients and controls will be asked to follow targets to remembered locations and their eye movements will be monitored.
OUTCOME MEASURES:
Eye movements will be examined for evidence of internal monitoring (corollary discharge) defects which would result in mislocalizing remembered targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
Key exclusion criteria (2 listed)
- Large refractive error requiring strong glasses. Glasses may interfere with the video eye movement recording system. However, participants may wear contact lenses. Subjects with a history of eye disease affecting vision or eye movements will also be excluded.
- Participants with guardians will be excluded.
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
Comparison of recordings between groups
Time frame: End of study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 10509174Andreasen NC, Nopoulos P, O'Leary DS, Miller DD, Wassink T, Flaum M. Defining the phenotype of schizophrenia: cognitive dysmetria and its neural mechanisms. Biol Psychiatry. 1999 Oct 1;46(7):908-20. doi: 10.1016/s0006-3223(99)00152-3.
- Background: PubMed 19268845Campanella S, Guerit JM. How clinical neurophysiology may contribute to the understanding of a psychiatric disease such as schizophrenia. Neurophysiol Clin. 2009 Feb;39(1):31-9. doi: 10.1016/j.neucli.2008.12.002. Epub 2009 Jan 9.
- Background: PubMed 1422794Duhamel JR, Goldberg ME, Fitzgibbon EJ, Sirigu A, Grafman J. Saccadic dysmetria in a patient with a right frontoparietal lesion. The importance of corollary discharge for accurate spatial behaviour. Brain. 1992 Oct;115 ( Pt 5):1387-402. doi: 10.1093/brain/115.5.1387.
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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.
Edmond J FitzGibbon, M.D. principal investigator
National Eye Institute (NEI)
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 Schizophrenia, run by National Eye Institute (NEI) 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 2 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: stopped early, as of the sponsor's last update on 6 Oct 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 was stopped early. Results are not available in the source record.
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?
Comparison of recordings between groups (time frame: End of study). 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 NCT01011101, 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 Oct 2017.