NCT00331669

Brief Summary

The purpose of this randomized, double blind, multi-center study is to assess the efficacy and safety of bilateral pallidal deep brain stimulation in patients with tardive dystonia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2006

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 4, 2009

Status Verified

February 1, 2009

First QC Date

May 26, 2006

Last Update Submit

March 3, 2009

Conditions

DystoniaMovement Disorder

Keywords

deep brain stimulationpallidumtardive dystoniarandomizeddouble blindmulticenter

Outcome Measures

Primary Outcomes (1)

  • Improvement of the motor scale of Burke-Fahn-Marsden-Dystonia Rating Scale via blinded video assessment 3 months after starting DBS in comparison to sham-stimulated patients

    3 months

Secondary Outcomes (5)

  • AIMS

    3 months

  • Non-motor subscores of BMFDRS

    3 months

  • Visual analogue scales for both patients and treating physicians

    3 months

  • Quality of life (SF-36)

    3 months

  • Psychiatric assessment (HADS-D and PANSS)

    3 months

Study Arms (1)

1

PLACEBO COMPARATOR

device

Procedure: deep brain stimulation

Interventions

deep brain stimulationPROCEDURE

high frequency stimulation

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Operational criteria for tardive dystonia for \> 18 months after cessation of neuroleptic exposure
  • years
  • Relevant functional impairment in daily living activities
  • BFMDRS \> 8 or AIMS \> 16
  • Informed written consent

You may not qualify if:

  • PANNS \>60 (Schizophrenia)
  • Hamilton-Score \> 18 (Depression)
  • MATTIS-Score \<120 (Dementia)
  • Preceding stereotactic neurosurgery
  • Pronounced brain atrophy
  • Increased bleeding risk
  • Decreased immune status
  • Botulinum Toxin treatment within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andreas Kupsch

Berlin, 13353, Germany

RECRUITING

Related Publications (4)

  • Trottenberg T, Volkmann J, Deuschl G, Kuhn AA, Schneider GH, Muller J, Alesch F, Kupsch A. Treatment of severe tardive dystonia with pallidal deep brain stimulation. Neurology. 2005 Jan 25;64(2):344-6. doi: 10.1212/01.WNL.0000149762.80932.55.

    PMID: 15668437BACKGROUND

  • Franzini A, Marras C, Ferroli P, Zorzi G, Bugiani O, Romito L, Broggi G. Long-term high-frequency bilateral pallidal stimulation for neuroleptic-induced tardive dystonia. Report of two cases. J Neurosurg. 2005 Apr;102(4):721-5. doi: 10.3171/jns.2005.102.4.0721.

    PMID: 15871516BACKGROUND

  • Damier P, Thobois S, Witjas T, Cuny E, Derost P, Raoul S, Mertens P, Peragut JC, Lemaire JJ, Burbaud P, Nguyen JM, Llorca PM, Rascol O; French Stimulation for Tardive Dyskinesia (STARDYS) Study Group. Bilateral deep brain stimulation of the globus pallidus to treat tardive dyskinesia. Arch Gen Psychiatry. 2007 Feb;64(2):170-6. doi: 10.1001/archpsyc.64.2.170.

    PMID: 17283284BACKGROUND

  • Gruber D, Sudmeyer M, Deuschl G, Falk D, Krauss JK, Mueller J, Muller JU, Poewe W, Schneider GH, Schrader C, Vesper J, Volkmann J, Winter C, Kupsch A, Schnitzler A; DBS study group for dystonia. Neurostimulation in tardive dystonia/dyskinesia: A delayed start, sham stimulation-controlled randomized trial. Brain Stimul. 2018 Nov-Dec;11(6):1368-1377. doi: 10.1016/j.brs.2018.08.006. Epub 2018 Sep 11.

    PMID: 30249417DERIVED

MeSH Terms

Conditions

DystoniaMovement DisordersTardive Dyskinesia

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System DiseasesDyskinesia, Drug-Induced

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Andreas R Kupsch, MD

    Dpt. of Neurology, Augustenburger Platz 1, 13353 Berlin, Charite, Campus Virchow, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas R Kupsch, MD, PhD

CONTACT

xx49-30-450-50andreas.kupsch@charite.de

Andrea Kuehn, MD

CONTACT

xx49-30-450-50andrea.kuehn@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 31, 2006

Study Start

May 1, 2006

Study Completion

December 1, 2010

Last Updated

March 4, 2009

Record last verified: 2009-02

Locations

DE(1)