Brain Changes in Blepharospasm
Suppression and Facilitation of the Motor Cortex by Stimulation of the Cerebellum in Patients With Dystonia and Healthy Controls
2 other identifiers
observational
47
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 P25-P50 for all trials
Started Jun 2007
Longer than P75 for all trials
1 active site
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
June 12, 2007
CompletedFirst Submitted
Initial submission to the registry
June 15, 2007
CompletedFirst Posted
Study publicly available on registry
June 18, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2012
CompletedDecember 16, 2019
June 29, 2012
June 15, 2007
December 13, 2019
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
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)
Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Sole J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433-44. doi: 10.1111/j.1468-1331.2006.01537.x.
PMID: 16722965BACKGROUNDAramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. doi: 10.1016/s0140-6736(05)71235-6. No abstract available.
PMID: 11254003BACKGROUNDAramideh M, Ongerboer de Visser BW, Holstege G, Majoie CB, Speelman JD. Blepharospasm in association with a lower pontine lesion. Neurology. 1996 Feb;46(2):476-8. doi: 10.1212/wnl.46.2.476.
PMID: 8614517BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 15, 2007
First Posted
June 18, 2007
Study Start
June 12, 2007
Study Completion
June 29, 2012
Last Updated
December 16, 2019
Record last verified: 2012-06-29