Status:
COMPLETED
Brain Stimulation to Treat Blepharospasm or Meige Syndrome
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Blepharospasm
Focal Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 closu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA PATIENTS:
- Patients with idiopathic BSP or Meige-Syndrome (=BSP plus oromandibular dystonia).
- Age 18 years or older.
- Normal findings in the medical history, physical and neurological examination, except for dystonia (in cases that patients have not had an H\& P at the NIH within the last 12 months; they will undergo all these exams on the first study day).
- Last treatment with botulinum toxin more than three months ago.
- INCLUSION CRITERIA CONTROLS:
- Age 18 years or older
- Normal findings in the medical history, physical and neurological examination
- No history of neuroleptic medications/ prior use of neuroleptics (such as Haldol(Registered Trademark))
- Not been treated or taken anti-depressants, anti-seizure medication, anticholinergic drugs (such as Artane(Registered Trademark)) and muscle relaxants within the past 4 weeks
- EXCLUSION CRITERIA PATIENTS:
- Any of the following will exclude a patient from the study:
- Other disease with involuntary blinking (Hemifacial spasm, Tic disorder, Tardive Dyskinesia, Tardive dystonia, etc).
- BSP and normal recovery of R2 in BRR.
- Participation in a clinical trial in the 2 weeks preceding the study.
- History of seizure disorder.
- Pregnancy- a pregnancy test will be performed for women of childbearing potential.
- Symptoms of a clinically relevant illness in the 4 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications or anti-seizure meds., anticholinergic drugs and muscle relaxants.
- History of neuroleptic medications/prior use of neuroleptics.
- 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.
Exclusion
Key Trial Info
Start Date :
June 22 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00411255
Start Date
June 22 2006
End Date
April 7 2009
Last Update
July 2 2017
Active Locations (1)
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1
National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville
Bethesda, Maryland, United States, 20892