Clinical Trial: Blepharospasm Tools

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:

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.


Sponsor: Emory University

Current Primary Outcome:

  • 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.
  • 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.
  • Blepharospasm Screening Questions - Motor (BSQ-M) [ Time Frame: Day 1 ]
  • 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).
  • Blepharospasm Disability Index (BSDI) [ Time Frame: Day 1 ]


Original Primary Outcome:

  • Blepharospasm Severity Rating Scale [ Time Frame: Day 1 ]
  • Blepharospasm Diagnostic Rating Scale [ Time Frame: Day 1 ]
  • Blepharospasm Screening Questions - Motor [ Time Frame: Day 1 ]
  • Blepharospasm Screening Questions - Psych [ Time Frame: Day 1 ]
  • Blepharospasm - mini [ Time Frame: Day 1 ]
    Severity rating scale for blepharospasm


Current Secondary Outcome:

  • Craniocervical Dystonia Questionnaire (CDQ-24) [ Time Frame: Day 1 ]
  • Eye Symptoms in Blepharospasm [ Time Frame: Day 1 ]
  • Jankovic Rating Scale (JRS) [ Time Frame: Day 1 ]
  • Oromandibular Dystonia Questionnaire (OMDQ-25) [ Time Frame: Day 1 ]
  • Obsessive Compulsive Inventory-Revised Edition (OCI-R) [ Time Frame: Day 1 ]
  • Global Dystonia Rating Scale (GDRS) [ Time Frame: Day 1 ]
  • Fahn-Marsden Dystonia Scale (FM) [ Time Frame: Day 1 ]
  • 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).
  • 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).
  • 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).
  • 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).
  • Short Form Health Survey-36 Quality of Life Scale (SF-36) [ Time Frame: Day 1 ]


Original Secondary Outcome:

Information By: Emory University

Dates:
Date Received: May 18, 2016
Date Started: August 2016
Date Completion: June 2019
Last Updated: April 7, 2017
Last Verified: April 2017