Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Deep brain stimulation (DBS)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dystonia focused on measuring cervical dystonia, torticollis, deep brain stimulation, pallidal stimulation, globus pallidus internus
Eligibility Criteria
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
Sites / Locations
- Medical University Innsbruck, Department of Neurology
- Department of Neurosurgery, Medical University Vienna
- Department of Neurology, Charité, Humboldt-University Berlin
- Clinic of Neurosurgery, Medical University Hannover
- Department of Neurology, University Heidelberg
- Department of Neurology, University Kiel
- Department for Stereotaxy and Functional Neurosurgery, University Cologne
- Department of Neurology, University Regensburg
- Department of Neurology, University Rostock
- Hertie-Institute for Clinical Brain Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
2
1
Arm Description
Sham-stimulation
Active GPI-DBS
Outcomes
Primary Outcome Measures
Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)
Secondary Outcome Measures
side-effects, quality of life, depression, pain, long-term efficacy
Full Information
NCT ID
NCT00148889
First Posted
September 7, 2005
Last Updated
February 15, 2018
Sponsor
German Parkinson Study Group (GPS)
Collaborators
Medtronic, Competence Network on Parkinson's Disease
1. Study Identification
Unique Protocol Identification Number
NCT00148889
Brief Title
Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Parkinson Study Group (GPS)
Collaborators
Medtronic, Competence Network on Parkinson's Disease
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
Keywords
cervical dystonia, torticollis, deep brain stimulation, pallidal stimulation, globus pallidus internus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Sham-stimulation
Arm Title
1
Arm Type
Active Comparator
Arm Description
Active GPI-DBS
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation (DBS)
Intervention Description
Bilateral pallidal stimulation with an implanted DBS device
Primary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
side-effects, quality of life, depression, pain, long-term efficacy
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Mueller, MD
Organizational Affiliation
Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck, Department of Neurology
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Department of Neurosurgery, Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Department of Neurology, Charité, Humboldt-University Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Clinic of Neurosurgery, Medical University Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Department of Neurology, University Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Department of Neurology, University Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Department for Stereotaxy and Functional Neurosurgery, University Cologne
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Department of Neurology, University Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Department of Neurology, University Rostock
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Hertie-Institute for Clinical Brain Research
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26074391
Citation
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.
Results Reference
derived
PubMed Identifier
25127231
Citation
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.
Results Reference
derived
Links:
URL
http://www.kompetenznetz-parkinson.de
Description
Homepage Competence Network on Parkinson's disease sponsored by the German government
Learn more about this trial
Double-blind, Multicenter Study to Assess the Efficacy of Bilateral Pallidal Stimulation in Patients With Medically Refractory Primary Cervical Dystonia
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