Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
405 participants
OBSERVATIONAL
2016-08-31
2019-03-20
Brief Summary
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Detailed Description
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* Provide a copy of medical records and provide a medical history relating to the diagnosis of blepharospasm.
* Have an examination by a neurologist or ophthalmologist to reveal the features and extent of dystonia or other eye and face disorders. The examination will be video recorded so it can be reviewed later by different experts.
* Complete some questionnaires about quality of life and psychiatric well being
The doctors will also complete various scales and questionnaires based on the participant's study visit.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Blepharospasm (BL)
Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well.
No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).
Disease Control Group
Participants in this group should be diagnosed with a disorder affecting their eyes or face, such as hemifacial spasm, facial tics, or apraxia.
No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).
Normal Control Group
Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face.
No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).
Interventions
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No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).
Eligibility Criteria
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Inclusion Criteria
* Sufficiently symptomatic at recruitment to ensure that (eye) problems are evident to evaluators.
* Has ability to provide informed consent and follow study directions.
* Diagnosed with a facial or eye disorder that can be confused with blepharospasm, including, but not limited to, hemifacial spasm, facial tics, psychogenic facial disorders, apraxia, and ptosis due to weakness. It is permissible for these problems to be part of Bell's palsy, myasthenia gravis, or Progressive Supranuclear Palsy (PSP).
* Has no significant dystonia in any body part.
* Sufficiently symptomatic at recruitment to ensure that (eye) problems are evident to evaluators.
* Has ability to provide informed consent and follow study directions.
* Has no facial or eye problem and no other neurological complaints.
Exclusion Criteria
* Suspected psychogenic movement or eye disorders.
* Has had surgical intervention for blepharospasm or eye problems that may confound interpretations, such as orbital myectomy, blepharoplasty, or deep brain stimulation surgery.
* Is being treated with dopamine receptor antagonists.
* Received BTX injection/botulinum toxin less than 10 weeks prior to study visit.
* Taking any concomitant medications that haven't been at stable doses for at least 1 month prior to study enrollment.
* Has significant medical or neurological conditions that preclude completing the video protocol and questionnaires.
* Has significant physical or other condition that would confound diagnosis or evaluation.
DISEASE CONTROL GROUP:
* Significant dystonia.
* Evidence of secondary blepharospasm as defined as blepharospasm caused by drug exposure or stroke.
* Received BTX injection/botulinum toxin less than 10 weeks prior to study visit.
* Taking any concomitant medications that haven't been at stable doses for at least 1 month prior to study enrollment.
* Unable to provide informed consent and follow study directions.
* Has significant medical or neurological conditions that preclude completing the video protocol and questionnaires.
* Has significant physical or other condition that would confound diagnosis or evaluation.
NORMAL CONTROL GROUP:
* Has facial or eye problem or other neurological complaints.
* Taking any concomitant medications that haven't been at stable doses for at least 1 month prior to study enrollment.
* Unable to provide informed consent and follow study directions.
* Has significant medical or neurological conditions that preclude completing the video protocol and questionnaires.
* Has significant physical or other condition that would confound diagnosis or evaluation.
18 Years
ALL
Yes
Sponsors
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Benign Essential Blepharospasm Research Foundation
OTHER
Emory University
OTHER
Responsible Party
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Hyder A. Jinnah, MD, PhD
Principal Investigator
Principal Investigators
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H. A. Jinnah, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Rush University
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
National Institutes of Health
Bethesda, Maryland, United States
Washington University in St. Louis
St Louis, Missouri, United States
Baylor College of Medicine
Houston, Texas, United States
Toronto Western Hospital
Toronto, Ontario, Canada
University Hospital of Schleswig-Holstein
Lübeck, , Germany
University of Bari
Bari, , Italy
University of Rome
Rome, , Italy
Countries
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Related Links
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Study description on Dystonia Coalition website
Other Identifiers
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IRB00087047
Identifier Type: -
Identifier Source: org_study_id
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