StrokeNCT01062672
Functional Neuroimaging of Cortical Plasticity in the Human Visual System
An observational study of Stroke and Blindness, run by Baylor College of Medicine at 2 sites in 2 countries.
Trial summary
The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2009to Dec 2015
- 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
Study population: Patients with lesions of the visual pathway (cortical or retinal)
Who may be able to join
- Stable lesion of the visual pathways resulting in a visual field scotoma.
Who cannot join
- Inability to undergo magnetic resonance imaging,
- Inability to comply with basic instructions,
- Inability to perform the behavioral tasks required,
- Patients with chronic progressive neurological or psychiatric disorders,
- Patients that are pregnant, or breast feeding.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Functional magnetic resonance imaging methods are used to monitor cortical topography in time. The main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.
- Keywords
- plasticity, reorganization, cortical, fMRI, rehabilitation
- Medical subject headings
- Stroke, Blindness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: PI left institution and no participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Eli M Mizrahi, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062672
- Sponsor's protocol ID
- H--22516
- Status last verified
- Apr 2022
- First submitted
- 3 Feb 2010
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging of Cortical Plasticity in the Human Visual System
- ClinicalTrials.gov ID
- NCT01062672
- Acronym / sponsor ID
- H--22516
- Keywords
- plasticity, reorganization, cortical, fMRI, rehabilitation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left institution and no participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jan 2009 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Feb 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.
The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Functional magnetic resonance imaging methods are used to monitor cortical topography in time. The main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.
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
- Study population
- Patients with lesions of the visual pathway (cortical or retinal)
Key inclusion criteria (1 listed)
- Stable lesion of the visual pathways resulting in a visual field scotoma.
Key exclusion criteria (5 listed)
- Inability to undergo magnetic resonance imaging,
- Inability to comply with basic instructions,
- Inability to perform the behavioral tasks required,
- Patients with chronic progressive neurological or psychiatric disorders,
- Patients that are pregnant, or breast feeding.
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Blindness, run by Baylor College of Medicine at 2 sites in 2 countries.
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 5 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: withdrawn, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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 withdrawn before enrolling participants, so there are no results.
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?
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 Apr 2022.