NCT02780336

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
4 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

May 18, 2016

Last Update Submit

May 30, 2019

Conditions

BlepharospasmDystoniaOther Eye and Face Disorders

Outcome Measures

Primary Outcomes (5)

  • 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

Secondary Outcomes (12)

  • Craniocervical Dystonia Questionnaire (CDQ-24)

    Day 1

  • Eye Symptoms in Blepharospasm

    Day 1

  • Jankovic Rating Scale (JRS)

    Day 1

  • Oromandibular Dystonia Questionnaire (OMDQ-25)

    Day 1

  • Obsessive Compulsive Inventory-Revised Edition (OCI-R)

    Day 1

  • +7 more secondary outcomes

Study Arms (3)

Blepharospasm (BL)

Participants in this group should be diagnosed with blepharospasm, but may have dystonia in other body parts as well.

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.

Other: No intervention.

Normal Control Group

Participants in this group should not have any neurologic problems or other disorders affecting patients eyes or face.

Other: No intervention.

Interventions

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).

Blepharospasm (BL)Disease Control GroupNormal Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • 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.
  • Significant dystonia.
  • Evidence of secondary blepharospasm as defined as blepharospasm caused by drug exposure or stroke.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

University Hospital of Schleswig-Holstein

Lübeck, 23562, Germany

Location

University of Bari

Bari, Italy

Location

University of Rome

Rome, Italy

Location

Related Links

MeSH Terms

Conditions

BlepharospasmDystonia

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesDyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • H. A. Jinnah, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 23, 2016

Study Start

August 1, 2016

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations

IT(2)US(7)DE(1)CA(1)