Status:
UNKNOWN
Efficacy and Safety of Deep Brain Stimulation (DBS) of the Pallidal (GPi) in Patients With Tardive Dystonia
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Humboldt-Universität zu Berlin
Ruhr University of Bochum
Conditions:
Dystonia
Movement Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this randomized, double blind, multi-center study is to assess the efficacy and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.
Detailed Description
Deep brain stimulation (DBS) has been established as a new reversible, neurosurgical therapeutic option for patients suffering from disabling neurological movement disorders such as essential tremor a...
Eligibility Criteria
Inclusion
- Operational criteria for tardive dystonia for \> 18 months after cessation of neuroleptic exposure
- 18-75 years
- Relevant functional impairment in daily living activities
- BFMDRS \> 8 or AIMS \> 16
- Informed written consent
Exclusion
- PANNS \>60 (Schizophrenia)
- Hamilton-Score \> 18 (Depression)
- MATTIS-Score \<120 (Dementia)
- Preceding stereotactic neurosurgery
- Pronounced brain atrophy
- Increased bleeding risk
- Decreased immune status
- Botulinum Toxin treatment within the last 3 months
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00331669
Start Date
May 1 2006
End Date
December 1 2010
Last Update
March 4 2009
Active Locations (1)
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1
Andreas Kupsch
Berlin, Germany, 13353