NCT00500799

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....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2009

Completed
Last Updated

July 2, 2017

Status Verified

April 14, 2009

First QC Date

July 12, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Transcranial Magnetic Stimulation (TMS)Blink ReflexBlepharospasmHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers (aged 18 or older) who are willing to participate.
  • Patients (aged 18 and older) with benign essential blepharospasm

You may not qualify if:

  • 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
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Baker RS, Andersen AH, Morecraft RJ, Smith CD. A functional magnetic resonance imaging study in patients with benign essential blepharospasm. J Neuroophthalmol. 2003 Mar;23(1):11-5. doi: 10.1097/00041327-200303000-00003.

    PMID: 12616082BACKGROUND
  • Cunnington R, Iansek R, Thickbroom GW, Laing BA, Mastaglia FL, Bradshaw JL, Phillips JG. Effects of magnetic stimulation over supplementary motor area on movement in Parkinson's disease. Brain. 1996 Jun;119 ( Pt 3):815-22. doi: 10.1093/brain/119.3.815.

    PMID: 8673493BACKGROUND
  • Gerschlager W, Siebner HR, Rothwell JC. Decreased corticospinal excitability after subthreshold 1 Hz rTMS over lateral premotor cortex. Neurology. 2001 Aug 14;57(3):449-55. doi: 10.1212/wnl.57.3.449.

    PMID: 11502912BACKGROUND

MeSH Terms

Conditions

Blepharospasm

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

July 9, 2007

Study Completion

April 14, 2009

Last Updated

July 2, 2017

Record last verified: 2009-04-14

Locations