Blepharospasm Tools

Dystonia Clinical Trial

Official title:

Diagnostic and Rating Tools for Blepharospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780336
• Other study ID #: IRB00087047
• Secondary ID: U54TR001456
• Status: Completed
• Start date: August 2016
• Est. completion date: March 20, 2019

Study information

• Verified date: May 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharospasm
• Dystonia
• Other Eye and Face Disorders

Intervention

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).

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario
Germany	University Hospital of Schleswig-Holstein	Luebeck
Italy	University of Bari	Bari
Italy	University of Rome	Rome
United States	Emory University	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	National Institutes of Health	Bethesda	Maryland
United States	Rush University	Chicago	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Benign Essential Blepharospasm Research Foundation

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Blepharospasm Screening Questions - Motor (BSQ-M)		Day 1
Primary	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
Primary	Blepharospasm Disability Index (BSDI)		Day 1
Secondary	Craniocervical Dystonia Questionnaire (CDQ-24)		Day 1
Secondary	Eye Symptoms in Blepharospasm		Day 1
Secondary	Jankovic Rating Scale (JRS)		Day 1
Secondary	Oromandibular Dystonia Questionnaire (OMDQ-25)		Day 1
Secondary	Obsessive Compulsive Inventory-Revised Edition (OCI-R)		Day 1
Secondary	Global Dystonia Rating Scale (GDRS)		Day 1
Secondary	Fahn-Marsden Dystonia Scale (FM)		Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Short Form Health Survey-36 Quality of Life Scale (SF-36)		Day 1

External Links

•   Study description on Dystonia Coalition website