Parkinson's DiseasePhase 3NCT00196911
STN-Stimulation Versus Best Medical Treatment in Advanced PD
A Phase 3 study testing Implantation of stimulation electrodes in the STN in people with Parkinson's Disease, run by German Parkinson Study Group (GPS) at 6 sites in Germany.
Trial summary
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Implantation of stimulation electrodes in the STN
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2001to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2
Who cannot join
- age>75 years depression psychosis surgical contraindications
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Neurologische Klinik der Charité, Augustenburgerplatz 1
Berlin, 13353
Neurologische Klinik der Universität, Gleuelerstr. 50
Cologne, 50931
Neurologische Klinik der Universität, Moorenstr. 5
Düsseldorf, 40225
Neurologische Klinik der Universität, Neuenheimerfeld 400
Heidelberg, 69120
Department of Neurology, Schittenhelmstr. 10
Kiel, 24105
Neurologische Klinik der Universität
München, 81337
About this study
Official title: Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.
Read the detailed description
Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.
- Conditions
- Parkinson's Disease
- Being tested
- Implantation of stimulation electrodes in the STN
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of stimulation electrodes in the STNProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Motor Score in the OFF (UPDRS III)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants
Sponsor and investigators
- Lead sponsor
- German Parkinson Study Group (GPS)
- Sponsor type
- University, hospital or other
- Investigators
- Guenther Deuschl, Prof., Principal investigator, Department of Neurology, Christian-Albrechts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196911
- Sponsor's protocol ID
- A 125/00
- Other IDs
- Grant 01 GI 0201/01 GI 0401
- Status last verified
- Sep 2005
- First submitted
- 11 Sep 2005
- Last updated
- 30 Nov 2006
- Results posted
- No
Publications
Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.
PubMed 16943402Daniels C, Krack P, Volkmann J, Raethjen J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Is improvement in the quality of life after subthalamic nucleus stimulation in Parkinson's disease predictable? Mov Disord. 2011 Dec;26(14):2516-21. doi: 10.1002/mds.23907. Epub 2011 Aug 25.
PubMed 22170276Witt K, Daniels C, Krack P, Volkmann J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Negative impact of borderline global cognitive scores on quality of life after subthalamic nucleus stimulation in Parkinson's disease. J Neurol Sci. 2011 Nov 15;310(1-2):261-6. doi: 10.1016/j.jns.2011.06.028. Epub 2011 Jul 5.
PubMed 21733529Daniels C, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Risk factors for executive dysfunction after subthalamic nucleus stimulation in Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1583-9. doi: 10.1002/mds.23078.
PubMed 20589868Witt K, Daniels C, Reiff J, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Neuropsychological and psychiatric changes after deep brain stimulation for Parkinson's disease: a randomised, multicentre study. Lancet Neurol. 2008 Jul;7(7):605-14. doi: 10.1016/S1474-4422(08)70114-5. Epub 2008 Jun 4.
PubMed 18538636
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Prospective, Parallel-Group Study of the Effect of Deep Brain Stimulation (Subthalamic Nucleus) on Quality of Life and Motor Complications in Patients With Advanced Parkinson's Disease Compared With Best Medical Treatment
- ClinicalTrials.gov ID
- NCT00196911
- Acronym / sponsor ID
- A 125/00
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants
- Lead sponsor
- German Parkinson Study Group (GPS)University, hospital or other
- Study start
- Jan 2001
- Study completion
- Jan 2005
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.
Detailed description
Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- advanced Parkinson's disease with UPDRS III score >29/104 or Dyskinesia score > 2 or tremor >2
Key exclusion criteria (1 listed)
- age>75 years depression psychosis surgical contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of stimulation electrodes in the STN | Procedure or surgery | – |
Primary outcome
Quality of life
Motor Score in the OFF (UPDRS III)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2006.
- Results publication: PubMed 16943402Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.
- Derived from this study: PubMed 22170276Daniels C, Krack P, Volkmann J, Raethjen J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Is improvement in the quality of life after subthalamic nucleus stimulation in Parkinson's disease predictable? Mov Disord. 2011 Dec;26(14):2516-21. doi: 10.1002/mds.23907. Epub 2011 Aug 25.
- Derived from this study: PubMed 21733529Witt K, Daniels C, Krack P, Volkmann J, Pinsker MO, Kloss M, Tronnier V, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Negative impact of borderline global cognitive scores on quality of life after subthalamic nucleus stimulation in Parkinson's disease. J Neurol Sci. 2011 Nov 15;310(1-2):261-6. doi: 10.1016/j.jns.2011.06.028. Epub 2011 Jul 5.
- Derived from this study: PubMed 20589868Daniels C, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G, Witt K. Risk factors for executive dysfunction after subthalamic nucleus stimulation in Parkinson's disease. Mov Disord. 2010 Aug 15;25(11):1583-9. doi: 10.1002/mds.23078.
- Derived from this study: PubMed 18538636Witt K, Daniels C, Reiff J, Krack P, Volkmann J, Pinsker MO, Krause M, Tronnier V, Kloss M, Schnitzler A, Wojtecki L, Botzel K, Danek A, Hilker R, Sturm V, Kupsch A, Karner E, Deuschl G. Neuropsychological and psychiatric changes after deep brain stimulation for Parkinson's disease: a randomised, multicentre study. Lancet Neurol. 2008 Jul;7(7):605-14. doi: 10.1016/S1474-4422(08)70114-5. Epub 2008 Jun 4.
- German Research Collaboration, funded by the German Ministery of ResearchLink provided by the sponsor.
- Homepage Coordination Center for Clinical Studies to STN Study, Language: GermanLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guenther Deuschl, Prof. principal investigator
Department of Neurology, Christian-Albrechts University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Implantation of stimulation electrodes in the STN in people with Parkinson's Disease, run by German Parkinson Study Group (GPS) at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00196911, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2006.