Blepharospasm Tools



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:August 2016
End Date:April 2019
Contact:Adam Kassem
Email:akassem@emory.edu
Phone:404-727-3381

Use our guide to learn which trials are right for you!

Diagnostic and Rating Tools for Blepharospasm

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.

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 comprehensive evaluation for patients with blepharospasm, other eye and face
disorders, and people without any neurologic or eye or face disorders. It addresses abnormal
movements of the muscles around the eye, pain in those muscles, psychological accompaniments,
and impact on regular daily life. The evaluation for each participant will be done on a
single visit, and it may take up to 1.5 hours to complete. Each participant in this study
will be asked to do the following:

- 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.

BLEPHAROSPASM (BL) GROUP

Inclusion Criteria:

- 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 Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
8
sites
Bethesda, Maryland 20892
Principal Investigator: Mark Hallett, MD
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: H. A. Jinnah, MD, PhD
Phone: 404-727-3381
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Zoltan Mari, MD
Phone: 410-955-6672
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Joseph Jankovic, MD
Phone: 731-798-3951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Houston, TX
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Brian D. Berman, M.D., M.S.
Phone: 303-724-5865
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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Chicago, Illinois 60612
Principal Investigator: Cynthia Comella, MD
Phone: 312-942-4500
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Chicago, IL
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Saint Louis, Missouri 63110
Principal Investigator: Joel Perlmutter, MD
Phone: 314-362-7148
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Saint Louis, MO
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Toronto, Ontario
Principal Investigator: Susan Fox, MBChB, PhD
Phone: 416-603-5800
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Toronto,
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