Status:
COMPLETED
Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
Lead Sponsor:
German Parkinson Study Group (GPS)
Collaborating Sponsors:
Medtronic
Competence Network on Parkinson's Disease
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.
Detailed Description
Primary cervical dystonia (CD) affects about 20-40/100.000 population. The disease is chronic and life-long. The therapy of choice are local intramuscular Botulinum Toxin injections given every three ...
Eligibility Criteria
Inclusion
- Primary cervical dystonia
- Disease duration 3 years or longer
- Adult patient (18 years or older)
- TWSTRS severity score 15 or more
- Non-response to Botulinum Toxin
- Non-response to oral antidystonic medication
- Informed consent
Exclusion
- Dementia (Mattis Dementia Rating Scale below 120)
- Severe depression (Beck Depression Inventory \>25)
- Previous functional stereotactic surgery
- Hemidystonia or generalized dystonia
- Severe brain atrophy
- Contraindication against surgery
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00148889
Start Date
July 1 2005
End Date
April 1 2008
Last Update
February 19 2018
Active Locations (10)
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1
Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria, 6020
2
Department of Neurosurgery, Medical University Vienna
Vienna, Austria, 1090
3
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, Germany, 13353
4
Department for Stereotaxy and Functional Neurosurgery, University Cologne
Cologne, Germany, 50937