Blepharospasm Tools

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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