Brief Title
Blepharospasm Tools
Official Title
Diagnostic and Rating Tools for Blepharospasm
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 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.
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 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.
Study Type
Observational
Primary Outcome
Blepharospasm Diagnostic Rating Scale (BDRS)
Secondary Outcome
Craniocervical Dystonia Questionnaire (CDQ-24)
Condition
Blepharospasm
Intervention
No intervention.
Study Arms / Comparison Groups
Blepharospasm (BL)
Description: Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
405
Start Date
August 2016
Completion Date
March 20, 2019
Primary Completion Date
March 20, 2019
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
H. A. Jinnah, MD, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02780336
Organization ID
IRB00087047
Secondary IDs
U54TR001456
Responsible Party
Principal Investigator
Study Sponsor
Emory University
Collaborators
Benign Essential Blepharospasm Research Foundation
Study Sponsor
H. A. Jinnah, MD, PhD, Principal Investigator, Emory University
Verification Date
May 2019