Brain Changes in Blepharospasm

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Brief Title

Brain Changes in Blepharospasm

Official Title

Role of the Cortical Medial Frontal Areas in Blepharospasm

Brief Summary

      This study will examine the role of certain areas of the brain in blepharospasm, a type of
      dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable
      blinking or closing of the eyelids. The study will compare brain activity in healthy
      volunteers and in people with blepharospasm to find differences in the brain that may lead to
      better treatments for dystonia.

      Healthy volunteers and people with blepharospasm who are 18 years of age and older may be
      eligible for this study. All candidates are screened with a medical history. People with
      blepharospasm also have a physical examination and blepharospasm rating.

      Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in
      two 4-hour sessions, separated by 1 to 7 days.

      TMS

      A wire coil is held on the subject's scalp. A brief electrical current is passed through the
      coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may
      feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the
      face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles
      slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses
      delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.

      EMG

      Surface EMG is done during TMS to measure the electrical activity of muscles. For this test,
      electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the
      face....
    

Detailed Description

      Objectives

      This proposal will evaluate the role of an increase in excitability of the orbicularis oculi
      (OO) muscle representation in the medial frontal areas (supplementary motor areas, SMA) and
      anterior rostral cingulate: M3) in excessive blinking in patients with benign essential
      blepharospasm (BEB). We hypothesize that:

        1. at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS, targeting the SMA-M3, is
           more prominent in patients with BEP than in healthy control subjects,

        2. at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1, is almost
           the same in patients with BEP and in healthy control subjects,

        3. at rest, sICI of OO muscle will be decreased and ICF increased after stimulation of the
           SMA-M3 facial cortical area, in patients with BEP compared to healthy control subjects,

        4. at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1
           facial area in patients with BEP and healthy control subjects,

        5. in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent
           during voluntary blinking,

        6. in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent
           during involuntary blinking,

        7. in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during
           voluntary and involuntary blinking.

        8. it is possible to evoke consistent and reproducible motor evoked responses (MEP) in the
           orbicularis oculi (OO) muscles by stimulating the two main cortical representations of
           upper facial region: in the medial frontal wall (SMA and cingulate cortex - its rostral
           part, M3) and in the primary motor cortex (M1) with transcranial magnetic stimulation
           (TMS).

      Study population

      36 patients with BEB but without severe forceful closure of eyelids, 36 normal volunteers.

      Study design

      Subjects will have 3 visits:

      Visit 1: screening and blepharospasm score

      Visit 2: stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS (1Hz)
      with the Hesed coil (designed to stimulate deep brain).

      Visit 3: stimulation of the OO muscle representation in M1 using low frequency rTMS (1Hz)
      using a standard eight-shaped coil.

      Visits 2 and 3: single pulse TMS will be used to evoke MEPs from OO muscles. Paired pulse TMS
      will be used to assess sICI from OO muscles. The order of visits 2 and 3 will be randomly
      assigned.

      Outcome measures

      The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed
      before and after 15 minutes of low frequency rTMS. The secondary outcome measures will be the
      sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks.
    


Study Type

Observational




Condition

Blepharospasm



Publications

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

Recruitment Information



Estimated Enrollment

72

Start Date

July 9, 2007

Completion Date

April 14, 2009


Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Healthy volunteers (aged 18 or older) who are willing to participate.

          -  Patients (aged 18 and older) with benign essential blepharospasm

        EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:

          -  Subjects with a history of neurological or psychiatric disorder, current use or a
             history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or
             prolonged treatment, head injury with loss of consciousness, or epilepsy.

          -  Subjects receiving drugs acting primarily on the central nervous system

        EXCLUSION CRITERIA FOR PATIENTS:

          -  Subjects with a history of neurological disorders other than blepharospasm

          -  Subjects with a history of a psychiatric disorder, current use or a history of alcohol
             or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment,
             head injury with loss of consciousness, or epilepsy.

          -  Subjects receiving drugs acting primarily on the central nervous system

          -  Subjects who have been treated with botulinum toxin injections within 3 months prior
             to their participation in the study

          -  Subjects who are taking any medication for dystonia at the time of the study

          -  Subjects with severe forceful closure of eyelids, subjects scoring more than 20 on the
             Blepharospasm Disability scale (Lindeboom et al., 1995).

          -  Patients for whom participation in the study would, in the opinion of the
             investigators, cause undue stress or excessive apprehensiveness will also be excluded.
             The reason for that is that, in some patients, any stressful situation (like a medical
             exam or experiment) may cause a strong increase in the involuntary blink rate leading
             to a severe functional discomfort.

        The following exclusion criteria are due to the use of transcranial magnetic stimulation
        and repetitive transcranial magnetic stimulation up to 1Hz (Hallett 1999) for healthy
        volunteers and patients:

          -  Subjects with cardiac pacemakers, intracardiac lines, implanted medication pumps.

          -  Subjects with eye, blood vessel, cochlear, or eye implants.

          -  Subjects with increased intracranial pressure as evaluated by clinical means

          -  Subjects with metal in the cranium

          -  Subjects with dental braces (but dental fillings are not a problem), metal fragments
             from occupational exposure or surgical clips in or near the brain.

          -  Subjects with a personal or family history of hearing loss
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00500799

Organization ID

070191

Secondary IDs

07-N-0191


Study Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)


Study Sponsor

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Verification Date

April 14, 2009