Pupillary OcclusionNCT01759745
Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm
An observational study of Pupillary Occlusion, run by Kirsten Elwischger, MD at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupillary Occlusion
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2014to Dec 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients:
- Willing to participate
- Idiopathic blepharospasm
- Age 18-80
- Last botulinum toxin injection <3months
- Control:
Show all 9Show fewer
- Willing to participate
- Age and sex matched with patients
- Age18-80
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurology, Medical University of Vienna
Vienna, 1090
About this study
Official title: The Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm- a Pilot Study.
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).
Read more
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.
- Conditions
- Pupillary Occlusion
- Medical subject headings
- Pupil Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blepharospasm | Blepharospasm, patient's group | |
| Control | Healthy control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration and frequency of pupillary occlusion
Duration and frequency of pupillary occlusion during different tasks and situations will be studied via videooculography
Measured: At baseline
Secondary outcomes (1)
Number of blinks and spasms.
Number of blinks and spasms, registered by videotape of the eyes during different tasks and situations.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startDec 2014 (estimated)
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Organisatory reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pupillary OcclusionStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsten Elwischger, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kirsten Elwischger, MD, Medical University of Vienna
- Investigators
- Thomas Sycha, Prof.Dr., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759745
- Sponsor's protocol ID
- BEB_Gaze_Emotion
- Status last verified
- Feb 2021
- First submitted
- 31 Dec 2012
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6838174Weiner WJ, Nora LM. "Trick" movements in facial dystonia. J Clin Psychiatry. 1984 Dec;45(12):519-21.
PubMed 6501239Burke 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.
PubMed 3966004Richard 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.
PubMed 19966652Evinger 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.
PubMed 7813670
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Gaze Shift and Emotions on Symptoms of Blepharospasm- a Pilot Study.
- ClinicalTrials.gov ID
- NCT01759745
- Acronym / sponsor ID
- BEB_Gaze_Emotion
- Conditions
- Pupillary Occlusion
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Organisatory reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kirsten Elwischger, MDUniversity, hospital or other
- Study start
- Dec 2014 (estimated)
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Jan 2013 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blepharospasm | – | –Blepharospasm, patient's group |
| Control | – | –Healthy control subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Willing to participate
- Idiopathic blepharospasm
- Age 18-80
- Last botulinum toxin injection <3months
- Willing to participate
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration and frequency of pupillary occlusion
Time frame: At baseline
Duration and frequency of pupillary occlusion during different tasks and situations will be studied via videooculography
1 secondary outcome
Number of blinks and spasms.
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 6838174Jankovic 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.
- Background: PubMed 6501239Weiner WJ, Nora LM. "Trick" movements in facial dystonia. J Clin Psychiatry. 1984 Dec;45(12):519-21.
- Background: PubMed 3966004Burke 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.
- Background: PubMed 19966652Richard 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.
- Background: PubMed 7813670Evinger 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.
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.
Thomas Sycha, Prof.Dr. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pupillary Occlusion, run by Kirsten Elwischger, MD at 1 site in Austria.
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 9 inclusion and 14 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: withdrawn, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 was withdrawn before enrolling participants, so there are no results.
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?
Duration and frequency of pupillary occlusion (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759745, which also lists 5 linked publications.
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 1 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.