Clinical trial NCT02780336: Blepharospasm Tools
Official title: Diagnostic and Rating Tools for Blepharospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blepharospasm
Dystonia
Other Eye and Face Disorders
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Benign Essential Blepharospasm Research Foundation
First posted: 2016-05-23
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Blepharospasm Diagnostic Rating Scale (BDRS)
timeFrame: Day 1
measure: Blepharospasm Severity Rating Scale (BSRS)
timeFrame: Day 1
measure: Blepharospasm Screening Questions - Motor (BSQ-M)
timeFrame: Day 1
measure: Blepharospasm Screening Questions - Psych (BSQ-P)
timeFrame: Day 1
measure: Blepharospasm Disability Index (BSDI)
timeFrame: Day 1
Secondary outcomes:
measure: Craniocervical Dystonia Questionnaire (CDQ-24)
timeFrame: Day 1
measure: Eye Symptoms in Blepharospasm
timeFrame: Day 1
measure: Jankovic Rating Scale (JRS)
timeFrame: Day 1
measure: Oromandibular Dystonia Questionnaire (OMDQ-25)
timeFrame: Day 1
measure: Obsessive Compulsive Inventory-Revised Edition (OCI-R)
timeFrame: Day 1
measure: Global Dystonia Rating Scale (GDRS)
timeFrame: Day 1
measure: Fahn-Marsden Dystonia Scale (FM)
timeFrame: Day 1
measure: Beck Depression Inventory II (BDI-II)
timeFrame: Day 1
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Day 1
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Day 1
measure: Short Form Health Survey-36 Quality of Life Scale (SF-36)
timeFrame: Day 1
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health
state: Maryland
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Luebeck
country: Germany
facility: University Hospital of Schleswig-Holstein
city: Bari
country: Italy
facility: University of Bari
city: Rome
country: Italy
facility: University of Rome
Study officials:
affiliation: Emory University
name: H. A. Jinnah, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: