Efficacy and Safety of DBS of the GPi in Patients With Pr... | NCT00142259

Studies
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

NCT00142259

Sponsor

German Parkinson Study Group (GPS)

Status

Unknown status

Last Update Posted

Dec 6, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Dystonia

Interventions

Deep brain stimulation of the internal globus pallidus

Countries

Austria
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Grant: 01 GI 0201 / 01 GI 0401

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Not provided

Completion Date

Aug 2009

First Submitted Date

Sep 1, 2005

First Submission Date that Met QC Criteria

Sep 1, 2005

First Posted Date

Sep 2, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2006

Last Update Posted Date

Dec 6, 2006Estimated

Name	Class
Medtronic	INDUSTRY
Competence Network on Parkinson's Disease	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Deep brain stimulation of the internal globus pallidus	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline

Secondary Outcomes

Measure	Description	Time Frame
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Volkmann, MD, PhD	Dept. Neurology, UKSH Campus Kiel, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University Innsbruck, Department of Neurology		Innsbruck	Tyrol	6020	Austria
Klinikum der LMU, Neurologische Klinik

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17093249	Result	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.
33324891

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms