Trial record 20 of 25 for:    "Blepharospasm"

Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm

This study is not yet open for participant recruitment.
Verified December 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Kirsten Elwischger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01759745
First received: December 31, 2012
Last updated: January 2, 2013
Last verified: December 2012
  Purpose

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.


Condition
Pupillary Occlusion

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm- a Pilot Study.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Duration and frequency of pupillary occlusion [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Duration and frequency of pupillary occlusion during different tasks and situations will be studied via videooculography


Secondary Outcome Measures:
  • Number of blinks and spasms. [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Number of blinks and spasms, registered by videotape of the eyes during different tasks and situations.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blepharospasm
Blepharospasm, patient's group
Control
Healthy control subjects

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759745

Contacts
Contact: Gottfried Kranz, Doz.Dr. +43 1 40400 ext 3120 gottfried.kranz@meduniwien.ac.at
Contact: Kirsten Elwischger, Dr. +43 699 11605963 kirsten_elwischger@hotmail.com

Locations
Austria
Department of Neurology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Gottfried Kranz, Doz.Dr.    +43 1 40400 ext 3120    gottfried.kranz@meduniwien.ac.at   
Contact: Kirsten Elwischger, Dr.    +43 699 11605963    kirsten_elwischger@hotmail.com   
Sub-Investigator: Kirsten Elwischger, Dr.         
Sub-Investigator: Gottfried Kranz, Doz.Dr.         
Sponsors and Collaborators
Kirsten Elwischger, MD
Investigators
Principal Investigator: Thomas Sycha, Prof.Dr. Medical University of Vienna