NCT00142259

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 6, 2006

Status Verified

September 1, 2005

First QC Date

September 1, 2005

Last Update Submit

December 5, 2006

Conditions

Dystonia

Keywords

deep brain stimulationinternal globus pallidusdystonia

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Deep brain stimulation of the internal globus pallidusDEVICE

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mattis-Score \< 120
  • BDI \> 25
  • previous stereotactic brain surgery
  • severe brain atrophy
  • increased bleeding risk
  • immunosuppression and increased risk of infection
  • relevant cerebrovascular disease
  • psychiatric disorders, which might interfere with the cooperation in the study
  • other contraindications for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Medical University Innsbruck, Department of Neurology

Innsbruck, Tyrol, 6020, Austria

Location

Klinikum der LMU, Neurologische Klinik

München, Bavaria, 81377, Germany

Location

Neurologische Klinik am Klinikum der BJM-Universität

Würzburg, Bavaria, 97080, Germany

Location

Department of Neurology, Charité, Humboldt-University Berlin

Berlin, State of Berlin, 13353, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Department of Neurology, University Heidelberg

Heidelberg, 69120, Germany

Location

Dept. Neurology, UKSH Campus Kiel

Kiel, 24103, Germany

Location

Department of Neurology, University Rostock

Rostock, 18147, Germany

Location

Related Publications (3)

  • 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.

    PMID: 17093249RESULT

  • Steigerwald 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.

    PMID: 33324891DERIVED

  • Volkmann 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.

    PMID: 23123071DERIVED

Related Links

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Volkmann, MD, PhD

    Dept. Neurology, UKSH Campus Kiel, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

October 1, 2002

Study Completion

August 1, 2009

Last Updated

December 6, 2006

Record last verified: 2005-09

Locations

AU(1)DE(7)