Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
Prospective,Randomised, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Bilateral Globus Pallidus Internus - in Patients With Medically Refractory Primary Cervical Dystonia
Study Overview
Status
Conditions
Intervention / Treatment
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 months. Oral medication such as anticholinergics or dopamine depleting drugs are usually of limited efficacy or their use is limited by intolerable side-effects. About 5-10% of CD patients develop neutralizing antibodies against Botulinum Toxin. Two previous controlled multicenter trials have shown the efficacy and safety of bilateral pallidal stimulation in patients with primary segmental and generalized dystonia (one study was performed by our group).
Following surgery, patients will be randomized 1:1 to verum or placebo stimulation for a period of three months. Primary outcome measure is the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) - a validated and widely accepted physician-based outcome measure for cervical dystonia. The independent TWSTRS raters are movement disorders specialists unaware of the stimulation status (verum/placebo) and they compare the TWSTRS-score at baseline and 3-months follow-up. Our hypothesis is that stimulated patients will have a significantly better improvement of dystonia as compared to those without stimulation (placebo group).
After the 3-months period, all patients are unblinded and receive continuous effective stimulation by the implanted system. Regular follow-up visits are scheduled every 12 months for 5 years postoperatively to assess the long-term efficacy of pallidal stimulation. Side-effects are assessed in a standardized way and include the assessment of surgery-induced as well as stimulation-induced side-effects.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Department of Neurosurgery, Medical University Vienna
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Medical University Innsbruck, Department of Neurology
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Berlin, Germany, 13353
- Department of Neurology, Charité, Humboldt-University Berlin
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Hannover, Germany, 30625
- Clinic of Neurosurgery, Medical University Hannover
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Heidelberg, Germany, 69120
- Department of Neurology, University Heidelberg
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Kiel, Germany, 24105
- Department of Neurology, University Kiel
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Köln, Germany, 50937
- Department for Stereotaxy and Functional Neurosurgery, University Cologne
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Regensburg, Germany, 93053
- Department of Neurology, University Regensburg
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Rostock, Germany, 18147
- Department of Neurology, University Rostock
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Tübingen, Germany, 72076
- Hertie-Institute for Clinical Brain Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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SHAM_COMPARATOR: 2
Sham-stimulation
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Bilateral pallidal stimulation with an implanted DBS device
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ACTIVE_COMPARATOR: 1
Active GPI-DBS
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Bilateral pallidal stimulation with an implanted DBS device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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side-effects, quality of life, depression, pain, long-term efficacy
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Joerg Mueller, MD, Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria
Publications and helpful links
General Publications
- Dinkelbach L, Mueller J, Poewe W, Delazer M, Elben S, Wolters A, Karner E, Wittstock M, Benecke R, Schnitzler A, Volkmann J, Sudmeyer M. Cognitive outcome of pallidal deep brain stimulation for primary cervical dystonia: One year follow up results of a prospective multicenter trial. Parkinsonism Relat Disord. 2015 Aug;21(8):976-80. doi: 10.1016/j.parkreldis.2015.06.002. Epub 2015 Jun 4.
- Volkmann J, Mueller J, Deuschl G, Kuhn AA, Krauss JK, Poewe W, Timmermann L, Falk D, Kupsch A, Kivi A, Schneider GH, Schnitzler A, Sudmeyer M, Voges J, Wolters A, Wittstock M, Muller JU, Hering S, Eisner W, Vesper J, Prokop T, Pinsker M, Schrader C, Kloss M, Kiening K, Boetzel K, Mehrkens J, Skogseid IM, Ramm-Pettersen J, Kemmler G, Bhatia KP, Vitek JL, Benecke R; DBS study group for dystonia. Pallidal neurostimulation in patients with medication-refractory cervical dystonia: a randomised, sham-controlled trial. Lancet Neurol. 2014 Sep;13(9):875-84. doi: 10.1016/S1474-4422(14)70143-7. Epub 2014 Aug 7.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD-DBS-2005-JM
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