Status:
COMPLETED
Blepharospasm Tools
Lead Sponsor:
Emory University
Collaborating Sponsors:
Benign Essential Blepharospasm Research Foundation
Conditions:
Blepharospasm
Dystonia
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Blepharospasm is a chronic disorder characterized by too many contractions in the muscles around the eye and nearby facial muscles, leading to involuntary eye closure. This study involves a comprehens...
Eligibility Criteria
Inclusion
- BLEPHAROSPASM (BL) GROUP
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 20 2019
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT02780336
Start Date
August 1 2016
End Date
March 20 2019
Last Update
May 31 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
Emory University
Atlanta, Georgia, United States, 30329
3
Rush University
Chicago, Illinois, United States, 60612
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287