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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Competence Network on Parkinson's Disease | OTHER |
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The purpose of this study is to investigate the efficacy and safety of bilateral pallidal stimulation in patients with medically refractory primary cervical dystonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Sham Comparator | Sham-stimulation |
|
| 1 | Active Comparator | Active GPI-DBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation (DBS) | Device | Bilateral pallidal stimulation with an implanted DBS device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| side-effects, quality of life, depression, pain, long-term efficacy | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joerg Mueller, MD | Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck, Department of Neurology | Innsbruck | Tyrol | 6020 | Austria | ||
| Department of Neurosurgery, Medical University Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26074391 | Derived | 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. | |
| 25127231 |
| Label | URL |
|---|---|
| Homepage Competence Network on Parkinson's disease sponsored by the German government | View source |
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| Vienna |
| 1090 |
| Austria |
| Department of Neurology, Charité, Humboldt-University Berlin | Berlin | 13353 | Germany |
| Department for Stereotaxy and Functional Neurosurgery, University Cologne | Cologne | 50937 | Germany |
| Clinic of Neurosurgery, Medical University Hannover | Hanover | 30625 | Germany |
| Department of Neurology, University Heidelberg | Heidelberg | 69120 | Germany |
| Department of Neurology, University Kiel | Kiel | 24105 | Germany |
| Department of Neurology, University Regensburg | Regensburg | 93053 | Germany |
| Department of Neurology, University Rostock | Rostock | 18147 | Germany |
| Hertie-Institute for Clinical Brain Research | Tübingen | 72076 | Germany |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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