Protocol Number: 07-N-0191

Title:

Role of the Cortical Medial Frontal Areas in Blepharospasm

Number:

07-N-0191

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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

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

Special Instructions:

Currently Not Provided

Keywords:

Transcranial Magnetic Stimulation (TMS)

Blink Reflex

Recruitment Keyword(s):

Blepharospasm

Healthy Volunteer

HV

Condition(s):

Blepharospasm

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Baker RS, Andersen AH, Morecraft RJ, Smith CD. A functional magnetic resonance imaging study in patients with benign essential blepharospasm. J Neuroophthalmol. 2003 Mar;2 (1):11-5.

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.

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.

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