Status:
UNKNOWN
Bilateral Internal Pallidum Stimulation in Primary Generalized Dystonia
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Princess Beatrix Muscle Foundation
Conditions:
Dystonia
Primary Generalized Dystonia
Eligibility:
All Genders
12-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Primary generalized dystonia, also called idiopathic torsion dystonia or dystonia musculorum deformans is a disabling neurological condition which usually starts in childhood, mostly in a lower limb a...
Detailed Description
Study design and methods: This is a randomised, double-blind, placebo-controlled, multicentre study comparing the effect of bilateral DBS of the GPi with placebo in patients with invalidating primary...
Eligibility Criteria
Inclusion
- Invalidating primary generalized dystonia (BFMDRS-motor part \>= 35)
- Disease duration \>= 5 yrs
- Age at surgery between 12 and 60
- Insufficient improvement with pharmacological and physical therapy
- Signed informed consent, for patients \< 19 yrs of age a written consent of the parent(s) or caretaker(s) is needed.
Exclusion
- Mental retardation or dementia (MMSE \<24)
- Depressive state (HADS\>21)
- History of former stereotactic brain surgery
- Severe brain atrophy
- General surgical contraindications, such as uncontrolled hypertension or diabetes mellitus, cardiovascular or pulmonary risks, disturbances of bloodclotting.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00272246
Start Date
February 1 2005
End Date
December 1 2007
Last Update
January 5 2006
Active Locations (1)
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1
Department of Neurology, Movement Disorders Center
Amsterdam, Netherlands, 1100 DD