Brain Changes in Blepharospasm

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00487383
Collaborator
(none)
47
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective

    Besides alterations in the basal ganglia, substantial evidence identifies cerebellar dysfunction as a possible cause for dystonia. Pathophysiological findings suggest that the cerebellar influence on the primary motor cortex is modified in patients with different forms of dystonia. The objective of this study is to find out whether this cerebellar influence plays a role in dystonic disorders.

    Study population

    20 patients with blepharospasm, 20 patients with focal hand dystonia, 20 patients with DYT-1 Primary generalized dystonia and 60 healthy volunteers age and sex matched.

    Design

    Paired pulse transcranial magnetic stimulation (TMS) will be performed at rest and during tonic activation of the first dorsal interosseus muscle (FDI). The conditioning stimulus (CS) will be applied to the ipsilateral cerebellum using different intensities and will precede the test stimulus by intervals from 3 to 10 ms, respectively. The test stimulus (TS) will be applied over the motor hot spot of FDI in the primary motor cortex.

    Outcome measures

    The primary outcome measure will be the motor evoked potential (MEP) in FDI after a conditioning cerebellar stimulus in relation to the unconditioned MEP size. Each different patient group will be compared separately to the age- and sex-matched healthy controls and between each other. Secondary outcome parameters will be the influence of different interstimulus intervals and different stimulation intensities of the conditioning stimulus on the MEP.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    47 participants
    Time Perspective:
    Prospective
    Official Title:
    Suppression and Facilitation of the Motor Cortex by Stimulation of the Cerebellum in Patients With Dystonia and Healthy Controls
    Study Start Date :
    Jun 12, 2007
    Study Completion Date :
    Jun 29, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • INCLUSION CRITERIA:
      PATIENTS:
      • Age 18 years or older

      • Normal findings in the medical history, physical and neurological examination, except for dystonia

      HEALTHY CONTROLS:
      • Age 18 years or older

      • Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems

      EXCLUSION CRITERIA:
      Any of the following will exclude patients and controls from the study:
      • Secondary forms of dystonia, including tardive dyskinesia

      • History of seizure disorder

      • Symptoms of a clinically relevant illness in the 2 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications, anti-seizure medications, anticholinergic drugs, and muscle relaxants

      • Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines

      • History of neuroleptic medications

      • Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye

      • Botulinum toxin injection within 3 months of starting the protocol

      • Known hearing loss

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute of Neurological Disorders and Stroke (NINDS)

      Investigators

      • Principal Investigator: Mark Hallett, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00487383
      Other Study ID Numbers:
      • 070165
      • 07-N-0165
      First Posted:
      Jun 18, 2007
      Last Update Posted:
      Dec 16, 2019
      Last Verified:
      Jun 29, 2012

      Study Results

      No Results Posted as of Dec 16, 2019