NCT00148889

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
2 countries

10 active sites

Status
completed

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

September 7, 2005

Last Update Submit

February 15, 2018

Conditions

Cervical Dystonia

Keywords

cervical dystoniatorticollisdeep brain stimulationpallidal stimulationglobus pallidus internus

Outcome Measures

Primary Outcomes (1)

  • Toronto Western Spasmodic Torticollis Scale (TWSTRS) at 3 months following surgery (comparison between placebo and control group)

    3 months

Secondary Outcomes (1)

  • side-effects, quality of life, depression, pain, long-term efficacy

    5 years

Study Arms (2)

2

SHAM COMPARATOR

Sham-stimulation

Device: Deep brain stimulation (DBS)

1

ACTIVE COMPARATOR

Active GPI-DBS

Device: Deep brain stimulation (DBS)

Interventions

Deep brain stimulation (DBS)DEVICE

Bilateral pallidal stimulation with an implanted DBS device

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Medical University Innsbruck, Department of Neurology

Innsbruck, Tyrol, 6020, Austria

Location

Department of Neurosurgery, Medical University Vienna

Vienna, 1090, Austria

Location

Department of Neurology, Charité, Humboldt-University Berlin

Berlin, 13353, Germany

Location

Department for Stereotaxy and Functional Neurosurgery, University Cologne

Cologne, 50937, Germany

Location

Clinic of Neurosurgery, Medical University Hannover

Hanover, 30625, Germany

Location

Department of Neurology, University Heidelberg

Heidelberg, 69120, Germany

Location

Department of Neurology, University Kiel

Kiel, 24105, Germany

Location

Department of Neurology, University Regensburg

Regensburg, 93053, Germany

Location

Department of Neurology, University Rostock

Rostock, 18147, Germany

Location

Hertie-Institute for Clinical Brain Research

Tübingen, 72076, Germany

Location

Related Publications (2)

  • 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.

    PMID: 26074391DERIVED

  • 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.

    PMID: 25127231DERIVED

Related Links

MeSH Terms

Conditions

Torticollis

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Joerg Mueller, MD

    Department of Neurology, Medical University Innsbruck, Anichstr. 35, A-6020 Innsbruck, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

July 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

DE(8)AU(2)