Blepharospasm Tools
Completed
Conditions studied: Blepharospasm, Dystonia, Other Eye and Face Disorders
In brief
The aim of this study is to develop new rating scales to help diagnose and measure the severity of blepharospasm. This is a condition involving a lot of blinking and spasms of eye closure that people can't control. This study will also test some video software to see if it can help diagnose people or tell the severity of disease using only a video recording of an exam. There is an additional plan to create an educational video to teach others the proper use of the scale and video software.
Key facts
- Study ID
- NCT02780336
- Run by
- Emory University
- People needed
- 405
- Starts
- 2016-08-01
- Expected to finish
- 2019-03-20
- Last updated by the study team
- 2019-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Diagnosed with Focal, Multifocal or Segmental Isolated Dystonia with Onset in Adulthood, must include blepharospasm.
- Sufficiently symptomatic at recruitment to ensure that (eye) problems are evident to evaluators.
- Has ability to provide informed consent and follow study directions.
You may not qualify if…
- Evidence of a secondary cause for dystonia as defined as blepharospasm caused by drug exposure, parkinsonism, or stroke.
- 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:
- Inclusion Criteria:
- 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.
- Exclusion Criteria:
- 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:
- Inclusion Criteria:
- Has no facial or eye problem and no other neurological complaints.
Where it is running
- 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
Full record on ClinicalTrials.gov
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