Degenerative Diseases of the Central Nervous SystemNCT00999934
Neural Mechanisms Engaged in Control of Eye Movements
An observational study of Degenerative Diseases of the Central Nervous System and Ocular-motor and Vestibular Diseases, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly, images must be held steady on the retina. Best visual acuity is achieved when the image of the object of interest is brought to and held on the fovea of the retina. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Diseases of the Central Nervous System, Ocular-motor and Vestibular Diseases
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to Feb 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center.
Who may be able to join
- Patients with degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies.
- Patients who are medically stable and are able to give informed consent will be included in the study.
Who cannot join
- Subjects with eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Neurology
Kfar Saba, Kfar Saba, 44281
Carlos R Gordon, MD, DSC, 972-9-7471581, cgordon@post.tau.ac.il
Carlos R Gordon, MD, DSc
About this study
The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly, images must be held steady on the retina. Best visual acuity is achieved when the image of the object of interest is brought to and held on the fovea of the retina. Two main types of eye movements are responsible for that: those that keep images stable on the retina (gaze holding mechanisms) and those that change the line of sight (gaze shifting mechanisms). Several functional classes of eye movements have been defined; each has distinctive physiological properties that suit best to its particular task. Thus, vestibular and optokinetic eye movements hold images of the seen world steady on the retina during perturbations of the head. Saccades are rapid eye movements that bring the image of an object of interest, detected in the periphery of vision, onto the fovea where it can be seen best. Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye movements place the images of a single object simultaneously onto both foveae.
Each functional class of eye movements relies on a different neural substrate. The clinical significance of it is that impairment of a specific class of eye movement points to involvement of distinct structures or pathways within the brain. Thus, abnormalities of ocular motility are often the clue to the anatomical localization of neurological disorders.
Read more
Significance: This study will contribute to understand how the brain governs production of eye movements, and provide better insight on interaction between sensory (visual) and motor (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify pathophysiological mechanisms underlying human diseases and will improve the investigators' ability to diagnose and encourage development of new therapeutic strategies.
Methods: The investigators will measure eye and head movements using the magnetic scleral search coil technique. The magnetic search coil technique is the most sensitive and accurate technique used in modern ocular motor and vestibular research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.
Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center.
Criteria for inclusion/exclusion: The investigators will study patients with neurological disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who are medically stable and are able to give informed consent will be included in the study. Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.
- Medical subject headings
- Vestibular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative measure of eye movement and vestibulo-ocular abnormalities
Measured: December 1, 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Diseases of the Central Nervous SystemStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos R Gordon, M.D.; D.Sc., Principal investigator, Department of Neurology, Meir Medical Center, Kfar Saba and Sackler Faculty of Medicine, Tel Aviv, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999934
- Sponsor's protocol ID
- eyemovements01
- Status last verified
- Apr 2016
- First submitted
- 21 Oct 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms Engaged in Control of Eye Movements
- ClinicalTrials.gov ID
- NCT00999934
- Acronym / sponsor ID
- eyemovements01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 22 Oct 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.
The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly, images must be held steady on the retina. Best visual acuity is achieved when the image of the object of interest is brought to and held on the fovea of the retina. Two main types of eye movements are responsible for that: those that keep images stable on the retina (gaze holding mechanisms) and those that change the line of sight (gaze shifting mechanisms). Several functional classes of eye movements have been defined; each has distinctive physiological properties that suit best to its particular task. Thus, vestibular and optokinetic eye movements hold images of the seen world steady on the retina during perturbations of the head. Saccades are rapid eye movements that bring the image of an object of interest, detected in the periphery of vision, onto the fovea where it can be seen best. Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye movements place the images of a single object simultaneously onto both foveae.
Each functional class of eye movements relies on a different neural substrate. The clinical significance of it is that impairment of a specific class of eye movement points to involvement of distinct structures or pathways within the brain. Thus, abnormalities of ocular motility are often the clue to the anatomical localization of neurological disorders.
Significance: This study will contribute to understand how the brain governs production of eye movements, and provide better insight on interaction between sensory (visual) and motor (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify pathophysiological mechanisms underlying human diseases and will improve the investigators' ability to diagnose and encourage development of new therapeutic strategies.
Methods: The investigators will measure eye and head movements using the magnetic scleral search coil technique. The magnetic search coil technique is the most sensitive and accurate technique used in modern ocular motor and vestibular research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.
Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center.
Criteria for inclusion/exclusion: The investigators will study patients with neurological disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who are medically stable and are able to give informed consent will be included in the study. Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center.
Key inclusion criteria (2 listed)
- Patients with degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies.
- Patients who are medically stable and are able to give informed consent will be included in the study.
Key exclusion criteria (1 listed)
- Subjects with eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters.
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
Quantitative measure of eye movement and vestibulo-ocular abnormalities
Time frame: December 1, 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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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.
Carlos R Gordon, M.D.; D.Sc. principal investigator
Department of Neurology, Meir Medical Center, Kfar Saba and Sackler Faculty of Medicine, Tel Aviv, Israel.
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 Degenerative Diseases of the Central Nervous System and Ocular-motor and Vestibular Diseases, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative measure of eye movement and vestibulo-ocular abnormalities (time frame: December 1, 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2017.