Brain Changes in Blepharospasm
|ClinicalTrials.gov Identifier: NCT00500799|
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : July 2, 2017
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.
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.
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....
|Condition or disease|
This proposal will evaluate the role of an increase in excitability of the orbicularis oculi (OO) muscle representation in the medial frontal areas (supplementary motor areas, SMA) and anterior rostral cingulate: M3) in excessive blinking in patients with benign essential blepharospasm (BEB). We hypothesize that:
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS, targeting the SMA-M3, is more prominent in patients with BEP than in healthy control subjects,
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1, is almost the same in patients with BEP and in healthy control subjects,
- at rest, sICI of OO muscle will be decreased and ICF increased after stimulation of the SMA-M3 facial cortical area, in patients with BEP compared to healthy control subjects,
- at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1 facial area in patients with BEP and healthy control subjects,
- in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent during voluntary blinking,
- in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent during involuntary blinking,
- in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during voluntary and involuntary blinking.
- it is possible to evoke consistent and reproducible motor evoked responses (MEP) in the orbicularis oculi (OO) muscles by stimulating the two main cortical representations of upper facial region: in the medial frontal wall (SMA and cingulate cortex - its rostral part, M3) and in the primary motor cortex (M1) with transcranial magnetic stimulation (TMS).
36 patients with BEB but without severe forceful closure of eyelids, 36 normal volunteers.
Subjects will have 3 visits:
Visit 1: screening and blepharospasm score
Visit 2: stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS (1Hz) with the Hesed coil (designed to stimulate deep brain).
Visit 3: stimulation of the OO muscle representation in M1 using low frequency rTMS (1Hz) using a standard eight-shaped coil.
Visits 2 and 3: single pulse TMS will be used to evoke MEPs from OO muscles. Paired pulse TMS will be used to assess sICI from OO muscles. The order of visits 2 and 3 will be randomly assigned.
The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed before and after 15 minutes of low frequency rTMS. The secondary outcome measures will be the sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks.
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|Official Title:||Role of the Cortical Medial Frontal Areas in Blepharospasm|
|Study Start Date :||July 9, 2007|
|Estimated Study Completion Date :||April 14, 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500799
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|