Brain Changes in Blepharospasm
Role of the Cortical Medial Frontal Areas in Blepharospasm
2 other identifiers
observational
72
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2007
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2007
CompletedFirst Submitted
Initial submission to the registry
July 12, 2007
CompletedFirst Posted
Study publicly available on registry
July 13, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2009
CompletedJuly 2, 2017
April 14, 2009
July 12, 2007
June 30, 2017
Conditions
Keywords
Eligibility Criteria
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
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: 12616082BACKGROUNDCunnington 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: 8673493BACKGROUNDGerschlager 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
Condition Hierarchy (Ancestors)
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