Efficacy and Safety of Deep Brain Stimulation (DBS) of the Pallidal (GPi) in Patients With Tardive Dystonia
NCT ID: NCT00331669
Last Updated: 2009-03-04
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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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2006-05-31
2010-12-31
Brief Summary
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Detailed Description
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Initially 60 patients had been calculated in a power analysis to assess significant results based on an average improvement of dystonic symptoms of 30%. However, in a recent study (Damier et al., Archives of General Psychiatry, 2007), 10 out of 10 showed a successful outcome of approximately 50% decrease on the extrapyramidal symptoms rating scale score. The exact one- sided lower 95% confidence limit would be 0.794 for this result. If such an approach is chosen for sample size estimation with 18 verum and 18 placebo patients one would obtain a power of 82% against a placebo effect of 30% success rate. For a placebo effect of 25% one needs 16+16 patients and for the placebo effect of 20% one needs 12+12 patients. We thus decided to reduce the sample size to 36- 32- 24 patients. It is expected that the continuous primary outcome measure will preserve even higher power than the binary one used in the study mentioned above. The local ethical committee has approved this.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
device
deep brain stimulation
high frequency stimulation
Interventions
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deep brain stimulation
high frequency stimulation
Eligibility Criteria
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Inclusion Criteria
* 18-75 years
* Relevant functional impairment in daily living activities
* BFMDRS \> 8 or AIMS \> 16
* Informed written consent
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Humboldt-Universität zu Berlin
OTHER
Ruhr University of Bochum
OTHER
Medical University of Cologne
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
University Hospital Freiburg
OTHER
Medical University of Hannover
OTHER
Medical University Innsbruck
OTHER
University of Kiel
OTHER
Philipps University Marburg
OTHER
Ludwig-Maximilians - University of Munich
OTHER
University of Rostock
OTHER
University of Regensburg
OTHER
University Hospital Tuebingen
OTHER
Medical University of Vienna
OTHER
Medtronic
INDUSTRY
Charite University, Berlin, Germany
OTHER
Principal Investigators
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Andreas R Kupsch, MD
Role: PRINCIPAL_INVESTIGATOR
Dpt. of Neurology, Augustenburger Platz 1, 13353 Berlin, Charite, Campus Virchow, Germany
Locations
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Andreas Kupsch
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Trottenberg T, Volkmann J, Deuschl G, Kuhn AA, Schneider GH, Muller J, Alesch F, Kupsch A. Treatment of severe tardive dystonia with pallidal deep brain stimulation. Neurology. 2005 Jan 25;64(2):344-6. doi: 10.1212/01.WNL.0000149762.80932.55.
Franzini A, Marras C, Ferroli P, Zorzi G, Bugiani O, Romito L, Broggi G. Long-term high-frequency bilateral pallidal stimulation for neuroleptic-induced tardive dystonia. Report of two cases. J Neurosurg. 2005 Apr;102(4):721-5. doi: 10.3171/jns.2005.102.4.0721.
Damier P, Thobois S, Witjas T, Cuny E, Derost P, Raoul S, Mertens P, Peragut JC, Lemaire JJ, Burbaud P, Nguyen JM, Llorca PM, Rascol O; French Stimulation for Tardive Dyskinesia (STARDYS) Study Group. Bilateral deep brain stimulation of the globus pallidus to treat tardive dyskinesia. Arch Gen Psychiatry. 2007 Feb;64(2):170-6. doi: 10.1001/archpsyc.64.2.170.
Gruber D, Sudmeyer M, Deuschl G, Falk D, Krauss JK, Mueller J, Muller JU, Poewe W, Schneider GH, Schrader C, Vesper J, Volkmann J, Winter C, Kupsch A, Schnitzler A; DBS study group for dystonia. Neurostimulation in tardive dystonia/dyskinesia: A delayed start, sham stimulation-controlled randomized trial. Brain Stimul. 2018 Nov-Dec;11(6):1368-1377. doi: 10.1016/j.brs.2018.08.006. Epub 2018 Sep 11.
Other Identifiers
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DBS and tardive dystonia
Identifier Type: -
Identifier Source: org_study_id
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