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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
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Full description
BACKGROUND: Blepharospasm (BSP) is a common form of focal dystonia, but the etiology and underlying pathophysiological mechanisms are still obscure. BSP is characterized by excessive involuntary closure of the eyelids. Pathological changes in excitability in the primary motor cortex (MC) and secondary motor areas, such as the anterior cingulate (AC), pre-and supplementary cortex (PMC, SMA) are suggested from electrophysiological and brain imaging studies. It is conceivable that modulation of excitability in some of these areas may lead to amelioration of the symptoms of BSP. Cortical excitability can be experimentally changed by various well-established electrophysiological techniques non-invasively.
METHODS: In this pilot protocol, studying 30 patients with BSP, we will use repetitive transcranial magnetic stimulation (rTMS) over the AC, PMC, SMA and MC in two different inhibitory modes: low frequency rTMS ((lf) rTMS) and continuous theta burst stimulation cTBS. Furthermore, we will apply transcranial direct stimulation (tDCS) in an inhibitory mode (cathodal tDCS) over the MC and low intensity high frequency supraorbital electrical stimulation; the latter will be performed in patients and in 7 healthy subjects. The effects on blepharospasm will be objectively measured by electrophysiological measures (blink reflex recovery curve (BRR), blink rate observation by an investigator blinded to the intervention, and a subjective rating by the patient.
OBJECTIVES: We hypothesize that we will find variable amounts of clinical improvement in BSP patients with these different methods. With this study, we aim to get more insight to the underlying pathophysiological mechanisms of BSP and identify which method of non-invasive brain stimulation may be clinically most efficacious.
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Inclusion and exclusion criteria
INCLUSION CRITERIA CONTROLS:
EXCLUSION CRITERIA PATIENTS:
Any of the following will exclude a patient from the study:
EXCLUSION CRITERIA CONTROLS:
A botulinum toxin injection within 3 months of starting the protocol
Any condition that requires the use of anti-depressants, anti-psychotic or anti-seizure medications
Cannot follow the instruction through the entire recording
Not able to provide consent to participate in the study
Patients will be screened and recruited from the outpatient clinic of the HMCS, NINDS. Age matched volunteers will be recruited from the NIH Patient Recruitment and Public Liaison Office.
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Data sourced from clinicaltrials.gov
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