NCT01759745

Brief Summary

Blepharospasm (BEB) is a focal dystonia characterized by forceful, involuntary contractions of the orbicularis oculi muscle. (Jankovic et al 1983) Patients with BEB report task and situation specific modulations of their symptoms. So called "sensory tricks" are actions that minimize symptoms and include concentrating, talking, pulling on the eyelids, blowing air, and applying pressure to the periocular or temple region. (Weiner 1984) Many patients describe that other tasks/situations are exacerbate their symptoms specifically under bright fluorescent lights and stress. (Burke 1984) Earlier studies showed that blink patterns differ between BEB patients and control during rest, reading and talking. In healthy subjects gaze evoked blinks are a physiologic phenomenon: initiation of gaze shifts evoke a blink, blinks facilitate gaze shifts. (Evinger 1994) In healthy subjects emotions and thoughts influence gaze shifts and blink rate. (Leal 2008, de Genaro 1988) However, little is known about various task and emotion specific influences on symptoms of BEB (e.g. expecting a gaze shift might worsen symptoms while driving a car). Differences in emotion and gaze related blink patterns between patients and controls will contribute to the understanding of the pathophysiology of BEB. This might offer new therapeutic options, e.g. symptom modulation. The investigators hypothesize that blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and control, when performing gaze shifts and emotion related blink patterns, measured by duration and frequency of pupillary occlusion differ between patients and controls. The aim of this pilot trial is to assess differences in gaze evoked and emotion related blink patterns between patients and controls. These differences might contribute to the understanding of the pathophysiology of BEB.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 31, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

December 31, 2012

Last Update Submit

February 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Duration and frequency of pupillary occlusion

    Duration and frequency of pupillary occlusion during different tasks and situations will be studied via videooculography

    At baseline

Secondary Outcomes (1)

  • Number of blinks and spasms.

    At baseline

Study Arms (2)

Blepharospasm

Blepharospasm, patient's group

Control

Healthy control subjects

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

20 patients suffering from BEB, age 18-80 from our Botulinum toxin clinic will be investigated. For controls,20 healthy age matched subjects will be investigated. All participants will sign an informed consent.

You may qualify if:

  • Patients:
  • Willing to participate
  • Idiopathic blepharospasm
  • Age 18-80
  • Last botulinum toxin injection \<3months
  • Control:
  • Willing to participate
  • Age and sex matched with patients
  • Age18-80

You may not qualify if:

  • Patients:
  • Secondary blepharospasm
  • Neurologic Comorbidities
  • Other eye disease besides BEB
  • History of neuroleptic medication
  • Use of medications on the study day, that influence eye blinks\& attention
  • Drinking of caffeine or theine containing beverages on the study day
  • Patients and Control:
  • Intake of psychotropic drugs at day of examination
  • History of neuroleptic medication
  • present eye disease
  • Neurologic diseases that influence blinking
  • Use of medications on the study day, that influence eye blinks\& attention
  • Drinking of caffeine or theine containing beverages on the study day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (5)

  • Jankovic J, Ford J. Blepharospasm and orofacial-cervical dystonia: clinical and pharmacological findings in 100 patients. Ann Neurol. 1983 Apr;13(4):402-11. doi: 10.1002/ana.410130406.

    PMID: 6838174BACKGROUND
  • Weiner WJ, Nora LM. "Trick" movements in facial dystonia. J Clin Psychiatry. 1984 Dec;45(12):519-21.

    PMID: 6501239BACKGROUND
  • Burke RE, Fahn S, Marsden CD, Bressman SB, Moskowitz C, Friedman J. Validity and reliability of a rating scale for the primary torsion dystonias. Neurology. 1985 Jan;35(1):73-7. doi: 10.1212/wnl.35.1.73.

    PMID: 3966004BACKGROUND
  • Richard MJ, Woodward DJ, McCoy AN, Woodward JA. Effect of reading on surface electromyogram recordings in patients with blepharospasm. Ophthalmic Plast Reconstr Surg. 2009 Sep-Oct;25(5):378-81. doi: 10.1097/IOP.0b013e3181b0d630.

    PMID: 19966652BACKGROUND
  • Evinger C, Manning KA, Pellegrini JJ, Basso MA, Powers AS, Sibony PA. Not looking while leaping: the linkage of blinking and saccadic gaze shifts. Exp Brain Res. 1994;100(2):337-44. doi: 10.1007/BF00227203.

    PMID: 7813670BACKGROUND

MeSH Terms

Conditions

Pupil Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Sycha, Prof.Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Kirsten Elwischger

Study Record Dates

First Submitted

December 31, 2012

First Posted

January 3, 2013

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations