Protocol Number: 06-N-0192

Title:

Blepharospasm and the Experimental Modulation of Cortical Excitability in Primary and Secondary Motor Areas. A Pilot Study.

Number:

06-N-0192

Summary:

This research study will examine whether magnetic or electrical stimulation of the brain can improve the involuntary closure of the eyelids in patients with blepharospasm or Meige syndrome; conditions that belong to a group of neurological disorders called dystonias. Blepharospasm and Meige syndrome cause excessive involuntary closure of the eyelids or blinking. In an earlier study of patients with writer's cramp, which is another form of dystonia, symptoms improved temporarily with brain stimulation.

Interested people 18 years of age or older with blepharospasm or Meige syndrome may be eligible for this study. Candidates are screened with a medical history, physical examination and a blink reflex test.

Participants undergo brain stimulation and evaluations before and after the stimulation to test the response, as follows:

Procedures

-Transcranial magnetic stimulation (TMS): A wire coil is held on the patient'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 the muscles of the face, arm or leg. The subject may be asked to tense certain muscles slightly or perform other simple actions. The effect of TMS on the muscles is detected with small metal disk electrodes taped to the skin of the arms or legs. TMS is done on eight of the ten test days.

-Repetitive TMS (rTMS): The same procedure as TMS, except repeated magnetic pulses are delivered in short bursts. RTMS is done on eight of the ten test days.

-Theta burst stimulation (TBS): A form of rTMS that involves short bursts of impulses. TBS is done on four study days.

-Cathodal transcranial DC stimulation (tDCS): Two conductive-rubber electrodes placed in saline-soaked sponges are positioned over two areas of the head. A constant weak electrical current flow is applied for 20 minutes. tDCS is done on two study days.

Evaluations

-Physician observation: The subject's eyes are videotaped for 5 minutes before and after each TMS session. A physician then counts how many times the subject blinked during the 5 minutes.

-Questionnaire: Subjects are asked to rate their symptoms before and after brain stimulation.

-Electrophysiological test of the blink reflex: Wires are taped to the skin on the nose and temple to record the eye movement during blinking. A thin plastic rod is placed on the skin over the right eyebrow and a small electrical current is passed through it to stimulate the eye muscle. The stimulus is applied to the muscle ten times to determine the least amount of stimuli needed to make the eye blink. Then six paired stimuli are applied to test the blink reflex.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Blink Reflex

Transcranial Magnetic Stimulation (TMS)

Dystonia

Recruitment Keyword(s):

Blepharospasm

BSP

Focal Dystonia

Condition(s):

Blepharospasm

Focal Dystonia

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Procedure/Surgery: repetitive transcranial magnetic stimulation (rTMS)

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Antal A, Kincses TZ, Nitsche MA, Bartfai O, Paulus W. Excitability changes induced in the human primary visual cortex by transcranial direct current stimulation: direct electrophysiological evidence. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):702-7.

Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6.

Aramideh M, Eekhof JL, Bour LJ, Koelman JH, Speelman JD, Ongerboer de Visser BW. Electromyography and recovery of the blink reflex in involuntary eyelid closure: a comparative study. J Neurol Neurosurg Psychiatry. 1995 Jun;58(6):692-8. Erratum in: J Neurol Neurosurg Psychiatry 1995 Dec;59(6):662.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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