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Blepharospasm Tools

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ClinicalTrials.gov Identifier: NCT02780336
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Benign Essential Blepharospasm Research Foundation
Information provided by (Responsible Party):
Hyder A. Jinnah, MD, PhD, Emory University

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.

Condition or disease Intervention/treatment
Blepharospasm Dystonia Other Eye and Face Disorders Other: No intervention.

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
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic and Rating Tools for Blepharospasm
Study Start Date : August 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


Group/Cohort Intervention/treatment
Blepharospasm (BL)
Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well.
Other: No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).

Disease Control Group
Participants in this group should be diagnosed with a disorder affecting their eyes or face, such as hemifacial spasm, facial tics, or apraxia.
Other: No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).

Normal Control Group
Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face.
Other: No intervention.
Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).




Primary Outcome Measures :
  1. Blepharospasm Diagnostic Rating Scale (BDRS) [ Time Frame: Day 1 ]
    The ratings for the BDRS will be examined for internal consistency by pair-wise correlations among all items in the scale in all combinations of possible pairs.

  2. Blepharospasm Severity Rating Scale (BSRS) [ Time Frame: Day 1 ]
    The ratings for the BSRS will be examined for internal consistency by pair-wise correlations among all items in the scale in all combinations of possible pairs.

  3. Blepharospasm Screening Questions - Motor (BSQ-M) [ Time Frame: Day 1 ]
  4. Blepharospasm Screening Questions - Psych (BSQ-P) [ Time Frame: Day 1 ]
    Concurrent validity for the BSQ-P will be assessed using correlations between the responses to the questionnaire and data from the corresponding scales included in the concurrent validity packet (BDI-II, HADS, LSAS and PHQ-9).

  5. Blepharospasm Disability Index (BSDI) [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Craniocervical Dystonia Questionnaire (CDQ-24) [ Time Frame: Day 1 ]
  2. Eye Symptoms in Blepharospasm [ Time Frame: Day 1 ]
  3. Jankovic Rating Scale (JRS) [ Time Frame: Day 1 ]
  4. Oromandibular Dystonia Questionnaire (OMDQ-25) [ Time Frame: Day 1 ]
  5. Obsessive Compulsive Inventory-Revised Edition (OCI-R) [ Time Frame: Day 1 ]
  6. Global Dystonia Rating Scale (GDRS) [ Time Frame: Day 1 ]
  7. Fahn-Marsden Dystonia Scale (FM) [ Time Frame: Day 1 ]
  8. Beck Depression Inventory II (BDI-II) [ Time Frame: Day 1 ]
    Concurrent validity for the BSQ-P will be assessed using correlations between the responses to the questionnaire and data from the corresponding scales included in the concurrent validity packet (BDI-II, HADS, LSAS and PHQ-9).

  9. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Day 1 ]
    Concurrent validity for the BSQ-P will be assessed using correlations between the responses to the questionnaire and data from the corresponding scales included in the concurrent validity packet (BDI-II, HADS, LSAS and PHQ-9).

  10. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 1 ]
    Concurrent validity for the BSQ-P will be assessed using correlations between the responses to the questionnaire and data from the corresponding scales included in the concurrent validity packet (BDI-II, HADS, LSAS and PHQ-9).

  11. Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Day 1 ]
    Concurrent validity for the BSQ-P will be assessed using correlations between the responses to the questionnaire and data from the corresponding scales included in the concurrent validity packet (BDI-II, HADS, LSAS and PHQ-9).

  12. Short Form Health Survey-36 Quality of Life Scale (SF-36) [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators hope to recruit 200 participants with blepharospasm, about 150 with other eye and face disorders, and 50 with no neurologic, eye or face disorder.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780336


Contacts
Contact: Adam Kassem 404-727-3381 akassem@emory.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Erika Shelton, B.S.    303-724-5865    erika.shelton@ucdenver.edu   
Principal Investigator: Brian D. Berman, M.D., M.S.         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Adam Kassem    404-727-3381    akassem@emory.edu   
Principal Investigator: H. A. Jinnah, MD, PhD         
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Samantha Ruehl    312-942-4500    Samantha_Ruehl@rush.edu   
Principal Investigator: Cynthia Comella, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Aathman Swaminathan    410-955-6672    aswamin2@jhmi.edu   
Principal Investigator: Zoltan Mari, MD         
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20892
Contact: Elaine Considine, RN       elaine.considine@nih.gov   
Principal Investigator: Mark Hallett, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jo Wright    314-362-7148    wrightl@npg.wustl.edu   
Principal Investigator: Joel Perlmutter, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Christine Hunter, RN, BSN    731-798-3951    chunter@bcm.edu   
Contact: Farah Ismail       farah.ismail@bcm.edu   
Principal Investigator: Joseph Jankovic, MD         
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada
Contact: Brandon Rothberg    416-603-5800 ext 3120    brothber@uhnresearch.ca   
Principal Investigator: Susan Fox, MBChB, PhD         
Germany
University Hospital of Schleswig-Holstein Recruiting
Luebeck, Germany, 23562
Contact: Susanna Langeloh    49 451 3101 8216    susanna.langeloh@neuro.uni-luebeck.de   
Principal Investigator: Christine Klein, MD         
Italy
University of Bari Recruiting
Bari, Italy
Contact: Angelo Gigante       gigante@yahoo.it   
Principal Investigator: Giovanni DeFazio, MD         
University of Rome Recruiting
Rome, Italy
Contact: Giovanni Fabbrini, MD       giovanni.fabbrini@uniroma1.it   
Principal Investigator: Alfredo Berardelli, MD         
Sponsors and Collaborators
Emory University
Benign Essential Blepharospasm Research Foundation
Investigators
Principal Investigator: H. A. Jinnah, MD, PhD Emory University

Additional Information:
Responsible Party: Hyder A. Jinnah, MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT02780336     History of Changes
Other Study ID Numbers: IRB00087047
U54TR001456 ( U.S. NIH Grant/Contract )
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Dystonia
Blepharospasm
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Eyelid Diseases
Eye Diseases