Study Stopped
Organisatory reason
Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm
The Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm- a Pilot Study.
1 other identifier
observational
N/A
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 1, 2021
February 1, 2021
1 year
December 31, 2012
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
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
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: 6838174BACKGROUNDWeiner WJ, Nora LM. "Trick" movements in facial dystonia. J Clin Psychiatry. 1984 Dec;45(12):519-21.
PMID: 6501239BACKGROUNDBurke 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: 3966004BACKGROUNDRichard 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: 19966652BACKGROUNDEvinger 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Sycha, Prof.Dr.
Medical University of Vienna
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