DystoniaPhase 4NCT00142259
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia
A Phase 4 study testing Deep brain stimulation of the internal globus pallidus in people with Dystonia, run by German Parkinson Study Group (GPS) at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep brain stimulation of the internal globus pallidus
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Oct 2002to Aug 2009
- Phase
- Phase 4
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of idiopathic multifocal, segmental or generalised dystonia
- duration of disease > 5 years
- age between 14 and 75 years
- relevant disability in activities of daily living despite optimal drug treatment
- informed consent signed by the patient
- For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary
Who cannot join
- Mattis-Score < 120
- BDI > 25
- previous stereotactic brain surgery
- severe brain atrophy
- increased bleeding risk
- immunosuppression and increased risk of infection
Show all 9Show fewer
- relevant cerebrovascular disease
- psychiatric disorders, which might interfere with the cooperation in the study
- other contraindications for surgery
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Department of Neurology, Charité, Humboldt-University Berlin
Berlin, State of Berlin, 13353
Study site
Düsseldorf
Department of Neurology, University Heidelberg
Heidelberg, 69120
Dept. Neurology, UKSH Campus Kiel
Kiel, 24103
Klinikum der LMU, Neurologische Klinik
München, Bavaria, 81377
Department of Neurology, University Rostock
Rostock, 18147
Neurologische Klinik am Klinikum der BJM-Universität
Würzburg, Bavaria, 97080
Austria1 site
Medical University Innsbruck, Department of Neurology
Innsbruck, Tyrol, 6020
About this study
Official title: Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.
- Conditions
- Dystonia
- Being tested
- Deep brain stimulation of the internal globus pallidus
- Keywords
- deep brain stimulation, internal globus pallidus, dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation of the internal globus pallidusDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
Secondary outcomes (1)
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2002
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- German Parkinson Study Group (GPS)
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Competence Network on Parkinson's Disease
- Investigators
- Jens Volkmann, MD, PhD, Principal investigator, Dept. Neurology, UKSH Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142259
- Sponsor's protocol ID
- 15
- Other IDs
- Grant: 01 GI 0201 / 01 GI 0401
- Status last verified
- Sep 2005
- First submitted
- 1 Sep 2005
- Last updated
- 6 Dec 2006
- Results posted
- No
Publications
Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.
PubMed 17093249Steigerwald F, Kirsch AD, Kuhn AA, Kupsch A, Mueller J, Eisner W, Deuschl G, Falk D, Schnitzler A, Skogseid IM, Vollmer-Haase J, Ip CW, Tronnier V, Vesper J, Naumann M, Volkmann J; DBS study group for dystonia. Evaluation of a programming algorithm for deep brain stimulation in dystonia used in a double-blind, sham-controlled multicenter study. Neurol Res Pract. 2019 Sep 24;1:25. doi: 10.1186/s42466-019-0032-2. eCollection 2019.
PubMed 33324891Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.
PubMed 23123071
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
- ClinicalTrials.gov ID
- NCT00142259
- Acronym / sponsor ID
- 15
- Conditions
- Dystonia
- Keywords
- deep brain stimulation, internal globus pallidus, dystonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- German Parkinson Study Group (GPS)University, hospital or other
- Collaborators
- Medtronic, Competence Network on Parkinson's Disease
- Study start
- Oct 2002
- Study completion
- Aug 2009
- First posted
- 2 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.
The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of idiopathic multifocal, segmental or generalised dystonia
- duration of disease > 5 years
- age between 14 and 75 years
- relevant disability in activities of daily living despite optimal drug treatment
- informed consent signed by the patient
Key exclusion criteria (9 listed)
- Mattis-Score < 120
- BDI > 25
- previous stereotactic brain surgery
- severe brain atrophy
- increased bleeding risk
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 |
|---|---|---|
| Deep brain stimulation of the internal globus pallidus | Device | – |
Primary outcome
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
1 secondary outcome
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2006.
- Results publication: PubMed 17093249Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.
- Derived from this study: PubMed 33324891Steigerwald F, Kirsch AD, Kuhn AA, Kupsch A, Mueller J, Eisner W, Deuschl G, Falk D, Schnitzler A, Skogseid IM, Vollmer-Haase J, Ip CW, Tronnier V, Vesper J, Naumann M, Volkmann J; DBS study group for dystonia. Evaluation of a programming algorithm for deep brain stimulation in dystonia used in a double-blind, sham-controlled multicenter study. Neurol Res Pract. 2019 Sep 24;1:25. doi: 10.1186/s42466-019-0032-2. eCollection 2019.
- Derived from this study: PubMed 23123071Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.
- Homepage Competence Network on Parkinson's disease sponsored by the German governmentLink 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.
Jens Volkmann, MD, PhD principal investigator
Dept. Neurology, UKSH Campus Kiel, Germany
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep brain stimulation of the internal globus pallidus in people with Dystonia, run by German Parkinson Study Group (GPS) at 8 sites in 2 countries.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline. 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 NCT00142259, which also lists 3 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 6 Dec 2006.