An observational study in Blepharospasm, Dystonia and Other Eye and Face Disorders, sponsored by Emory University. Completed at 11 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-31.
Sponsored by Emory University · Observational
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:
The doctors will also complete various scales and questionnaires based on the participant's study visit.
42 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's enrollment of 405 is above the median of 115 across 14 observational studies indexed under Blepharospasm.
Browse Blepharospasm studies →Emory University is the lead sponsor of 1,405 studies on the registry; 225 are open to participants now.
Of its 237 completed or terminated interventional studies of FDA-regulated products, 178 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
BLEPHAROSPASM (BL) GROUP
Inclusion Criteria:
Exclusion Criteria:
DISEASE CONTROL GROUP:
Inclusion Criteria:
Exclusion Criteria:
NORMAL CONTROL GROUP:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well.
Other: No intervention.
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 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).
Blepharospasm Diagnostic Rating Scale (BDRS)
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.
Time frame: Day 1
Blepharospasm Severity Rating Scale (BSRS)
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.
Time frame: Day 1
Blepharospasm Screening Questions - Motor (BSQ-M)
Time frame: Day 1
Blepharospasm Screening Questions - Psych (BSQ-P)
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).
Time frame: Day 1
Blepharospasm Disability Index (BSDI)
Time frame: Day 1
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)
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).
Time frame: Day 1
Patient Health Questionnaire 9 (PHQ-9)
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).
Time frame: Day 1
Hospital Anxiety and Depression Scale (HADS)
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).
Time frame: Day 1
Liebowitz Social Anxiety Scale (LSAS)
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).
Time frame: Day 1
Short Form Health Survey-36 Quality of Life Scale (SF-36)
Time frame: Day 1
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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