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| ID | Type | Description | Link |
|---|---|---|---|
| U54TR001456 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Benign Essential Blepharospasm Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blepharospasm (BL) | Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well. |
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| 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. |
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| Normal Control Group | Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1 |
| Blepharospasm Screening Questions - Motor (BSQ-M) | 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). | Day 1 |
| Blepharospasm Disability Index (BSDI) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Craniocervical Dystonia Questionnaire (CDQ-24) | Day 1 | |
| Eye Symptoms in Blepharospasm | Day 1 | |
| Jankovic Rating Scale (JRS) |
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BLEPHAROSPASM (BL) GROUP
Inclusion Criteria:
Exclusion Criteria:
DISEASE CONTROL GROUP:
Inclusion Criteria:
Exclusion Criteria:
NORMAL CONTROL GROUP:
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| H. A. Jinnah, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States | ||
| Emory University |
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| Label | URL |
|---|---|
| Study description on Dystonia Coalition website | View source |
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| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| D004421 | Dystonia |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
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| Day 1 |
| Oromandibular Dystonia Questionnaire (OMDQ-25) | Day 1 |
| Obsessive Compulsive Inventory-Revised Edition (OCI-R) | Day 1 |
| Global Dystonia Rating Scale (GDRS) | Day 1 |
| Fahn-Marsden Dystonia Scale (FM) | 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). | 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). | 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). | 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). | Day 1 |
| Short Form Health Survey-36 Quality of Life Scale (SF-36) | Day 1 |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| National Institutes of Health | Bethesda | Maryland | 20892 | United States |
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Toronto Western Hospital | Toronto | Ontario | Canada |
| University Hospital of Schleswig-Holstein | Lübeck | 23562 | Germany |
| University of Bari | Bari | Italy |
| University of Rome | Rome | Italy |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |