Combined STN/SNr-DBS for the Treatment of Refractory Gait Disorders in Parkinson's Disease
NCT ID: NCT01355835
Last Updated: 2012-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2011-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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[STNmono]
Conventional stimulation on subthalamic contacts
deep brain stimulation (ACTIVA PC, Medtronic)
High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
[STN+SNr]
Combined subthalamic and nigral stimulation
deep brain stimulation (ACTIVA PC, Medtronic)
High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
Interventions
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deep brain stimulation (ACTIVA PC, Medtronic)
High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: between 18 and 80 years
* Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms and therapy with STN-DBS (ACTIVA pulse generators) at least six months from surgery
* Optimized subthalamic stimulation at study enrolment (refer 'treatment' section)
* Gait disturbance refractory on best individual STN-DBS (STNmono) and dopaminergic therapy: 'gait score' in the best clinical \[MedOn/STNmono\] condition ≥ 12
* Clinical and image-guided (and facultatively electrophysiological) confirmation of (i) one of the two rostral contacts of the quadripolar electrode localized in the STN area, and (ii) the caudal contacts in the border zone of STN and SNr.
* Dopaminergic medication constant for at least four weeks prior to study enrolment
* Disease duration ≥ 5 years
Exclusion Criteria
* Participation in other clinical trials within the past three months and during enrolment in our study
* Suicidality, Psychosis
* Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
* Pregnancy
* Acute adverse events from stimulation on contacts in the caudal STN / SNr border interfering with the intended stimulation protocol
18 Years
80 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University Hospital Tuebingen
OTHER
Responsible Party
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Daniel Weiss
MD
Principal Investigators
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Daniel Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen
Rejko Krüger, MD
Role: PRINCIPAL_INVESTIGATOR
Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen
Locations
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Center of Neurology and Hertie Institute for Clinical Brain Research, and Department for Neurodegenerative Diseases, University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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References
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Weiss D, Breit S, Wachter T, Plewnia C, Gharabaghi A, Kruger R. Combined stimulation of the substantia nigra pars reticulata and the subthalamic nucleus is effective in hypokinetic gait disturbance in Parkinson's disease. J Neurol. 2011 Jun;258(6):1183-5. doi: 10.1007/s00415-011-5906-3. Epub 2011 Feb 2. No abstract available.
Weiss D, Wachter T, Meisner C, Fritz M, Gharabaghi A, Plewnia C, Breit S, Kruger R. Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial. Trials. 2011 Oct 11;12:222. doi: 10.1186/1745-6215-12-222.
Other Identifiers
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AKF 259-0-0
Identifier Type: -
Identifier Source: org_study_id