A Mechanical Device for Blepharospasm

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Brief Title

A Mechanical Device for Blepharospasm

Official Title

Clinical Trial of a Mechanical Device for the Treatment of Blepharospasm

Brief Summary

      Idiopathic blepharospasm (IB) is a rare but well characterised adult onset focal dystonia
      that may cause severe visual disability. The most effective treatment is with periodic
      injections of botulinum toxin into the pre-tarsal and / or pre-septal orbicularis oculi
      muscles bilaterally. However, even with treatment, practical visual function often remains
      compromised.

      A subset of IB sufferers find that eye opening improves with focal unilateral digital
      pressure usually on a specific point on the temple. The Investigators have developed a
      spectacle mounted spring-loaded prosthesis (the "Pressop" device) to apply continuous
      individually localised focal pressure on the temple to mimic the effect of finger pressure.

      The Investigators recommended a trial of this simple safe device in those IB patients who
      report improvement in eye opening with focal digital temple pressure.
    

Detailed Description

      Idiopathic blepharospasm is a rare chronic neuro-ophthalmic disorder that causes substantial
      visual handicap & compromises quality of life. It affects adults, women more than men,
      usually beginning in the 5th or 6th decade and consists of repeated forceful bilateral spasms
      of eye closure with photophobia and ocular surface discomfort. In up to a third of cases
      there are synchronous mid and / or lower facial spasms and the spectrum of disorder extends
      to cranial dystonia involving jaw & neck muscle spasms (e.g. antecollis or retrocollis).
      Practical visual function is variably affected but most patients will have to stop driving,
      many cannot work, manage the house or even leave the house unaccompanied. Leisure activities
      such as reading & watching television are compromised or impossible, and secondary mood
      dysphoria and depression are common.

      In some cases, patients have discovered that applying focal finger pressure, usually to the
      temple, relieves or even abolishes the spasms for the duration of the application. It is,
      however, difficult for the patient to sustain the finger pressure and impossible to apply it
      during activities when eyesight is important e.g. driving, typing or other bimanual tasks.
      The phenomenon can be regarded as the equivalent of the sensory trick (ST or geste
      antagonistique) seen in some cases of spasmodic torticollis whereby finger tip pressure on
      the chin prevents or reduces the muscle spasms in the neck and allows the head to be held
      straight.

      In this study, the Investigators explored the hypothesis that the benefit of the finger-tip
      pressure sensory trick could be replicated by a spring-loaded, spectacle mounted device
      applying focal pressure to the temple. Following preliminary design trials, the investigators
      commissioned a manufacturer to develop a light easily handled pressure device that could be
      fixed to the frame of most spectacles. The "Pressop" device fulfils these criteria and was
      adopted for the trial.
    


Study Type

Interventional


Primary Outcome

The study's objective and subjective responses for the use of the device is measured with the CDQ-24 questionnaire and a questionnaire specific to the the device

Secondary Outcome

 The proportion of patients demonstrating the "Geste Antagoniste" phenomenon.

Condition

Blepharospasm

Intervention

Pressop 1

Study Arms / Comparison Groups

 A device to relieve Blepharospasm
Description:  The pressure device known as Pressop1 is the intervention which is attached to the spectacles and worn for 2 weeks prior to retreatment with Botulinum Toxin injections to assess its effectiveness in controlling eyelid spasms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

58

Start Date

March 2, 2010

Completion Date

August 8, 2011

Primary Completion Date

August 8, 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Any adult patient with Blepharospasm of sufficient severity to necessitate repeated
             Botulinum injections can be included in the study.

          -  It is not essential for participants to be spectacle wearers (having a refractive
             error) as prescription free (zero power) spectacles can be provided for the purposes
             of being able to trial the device .

          -  The participants may or may not be currently having Botulinum Toxin injections. Some
             of these patients will be known to use the "Geste Antagoniste" phenomenon. Patients
             who may not know of this potential therapeutic effect will also be invited to trial
             the device.

        Exclusion Criteria:

          -  Inability to wear spectacles due to any reason (as the device has to be mounted on the
             spectacle frame).

          -  Patients who have spasms and twitches of the eyes caused by a different pathology e.g.
             Hemi facial Spasm, Parkinson's disease will also be excluded from this trial.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John S Elston, MD FRCS OPTH, , 



Administrative Informations


NCT ID

NCT03269123

Organization ID

5663


Responsible Party

Principal Investigator

Study Sponsor

Oxford University Hospitals NHS Trust

Collaborators

 The Dystonia Society of the United Kingdom

Study Sponsor

John S Elston, MD FRCS OPTH, Study Director, Oxford University Hospitals NHS Trust


Verification Date

August 2017