BlepharospasmNCT02780336
Blepharospasm Tools
An observational study of Blepharospasm and Dystonia, run by Emory University at 11 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharospasm, Dystonia, Other Eye and Face Disorders
- How many people
- 405 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Aug 2016to 20 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
- Has no facial or eye problem and no other neurological complaints.
Who cannot join
- 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.
Show all 22Show fewer
- 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:
- 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:
- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States7 sites
Emory University
Atlanta, Georgia, 30329
University of Colorado Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
National Institutes of Health
Bethesda, Maryland, 20892
Rush University
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Diagnostic and Rating Tools for Blepharospasm
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.
Read the 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.
- Conditions
- Blepharospasm, Dystonia, Other Eye and Face Disorders
- Being tested
- No intervention.
- Medical subject headings
- Blepharospasm, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Blepharospasm (BL) | Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well. Receives: Other: No intervention. | |
| 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. Receives: Other: No intervention. | |
| Normal Control Group | Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Blepharospasm Screening Questions - Motor (BSQ-M)
Measured: 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).
Measured: Day 1
Blepharospasm Disability Index (BSDI)
Measured: Day 1
Secondary outcomes (12)
Craniocervical Dystonia Questionnaire (CDQ-24)
Measured: Day 1
Eye Symptoms in Blepharospasm
Measured: Day 1
Jankovic Rating Scale (JRS)
Measured: Day 1
Oromandibular Dystonia Questionnaire (OMDQ-25)
Measured: Day 1
Obsessive Compulsive Inventory-Revised Edition (OCI-R)
Measured: Day 1
Global Dystonia Rating Scale (GDRS)
Measured: Day 1
Fahn-Marsden Dystonia Scale (FM)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 1
Short Form Health Survey-36 Quality of Life Scale (SF-36)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startAug 2016
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Benign Essential Blepharospasm Research Foundation
- Responsible party
- Principal investigator, Hyder A. Jinnah, MD, PhD, Emory University
- Investigators
- H. A. Jinnah, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780336
- Sponsor's protocol ID
- IRB00087047
- Other IDs
- U54TR001456
- Status last verified
- May 2019
- First submitted
- 18 May 2016
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Rating Tools for Blepharospasm
- ClinicalTrials.gov ID
- NCT02780336
- Acronym / sponsor ID
- IRB00087047
- Conditions
- Blepharospasm, Dystonia, Other Eye and Face Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Benign Essential Blepharospasm Research Foundation
- Study start
- Aug 2016
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blepharospasm (BL) | – | Other: No intervention.Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well. |
| Disease Control Group | – | 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. |
| Normal Control Group | – | Other: No intervention.Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Blepharospasm (BL), Disease Control Group, Normal Control Group |
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
12 secondary outcomes
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
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Day 1
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 1
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Day 1
Short Form Health Survey-36 Quality of Life Scale (SF-36)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Study description on Dystonia Coalition websiteLink provided by the sponsor.
Related trials for Blepharospasm
RecruitingPhase 2
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Blepharospasm of Both Eyelids, Blepharospasm of Left Eyelid
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
RecruitingObservational study
Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. A. Jinnah, MD, PhD principal investigator
Emory University
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm and Dystonia, run by Emory University at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Italy, Canada, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blepharospasm Diagnostic Rating Scale (BDRS) (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.