NCT00888095

Brief Summary

The aim of this study is to analyze the effects of two different targets of deep brain stimulation: caudal Zona incerta and Nucleus subthalamicus. The present study will investigate the effects of DBS using a blind, randomized and stratified design in patients with Parkinson's disease.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

April 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 22, 2009

Status Verified

July 1, 2009

Enrollment Period

3 years

First QC Date

April 23, 2009

Last Update Submit

July 21, 2009

Conditions

Parkinson's Disease

Keywords

deep brain stimulationcaudal Zona incertaNucleus subthalamicusParkinson's diseaserandomizedblindedMovement disorder

Outcome Measures

Primary Outcomes (1)

  • Improvement of scores (UPDRS III, PDQ-39) in Stim-ON and Med-OFF in a standard clinical check-up (CAPSIT) 12 and 24 months after operation compared to primary inclusion examination

    24 months

Secondary Outcomes (1)

  • Changes in dysarthria, other symptoms (subitems of UPDRS-III), dyskinesia (UPDRS-IV), impairment of gait, on-off fluctuations

    24 months

Study Arms (2)

1

EXPERIMENTAL

caudal Zona incerta (cZI)

Procedure: deep brain stimulation

2

EXPERIMENTAL

Nucleus subthalamicus (STN)

Procedure: deep brain stimulation

Interventions

deep brain stimulationPROCEDURE

electrode implantation in either STN or cZI

12

Eligibility Criteria

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

You may qualify if:

  • Idiopathic Parkinson's disease (criteria of the British Brain Bank: L-DOPA- or Apomorphin-sensitivity of more than 30% or typical Parkinsonian tremor while resting)
  • duration of disease \> 18 months
  • age between 18 and 75 Jahren
  • relevant disablement in daily activities/ impairment despite medical mental therapy
  • informed and signed consent of the patient

You may not qualify if:

  • Mattis Dementia Rating Scale-score \< 130
  • stereotactic brain operations in the past
  • significant brain atrophy
  • increased bleeding tendency
  • reduced infection defense
  • relevant cerebrovascular disease
  • a physical and/or mental illness which is likely to affect the study procedures in a negative way (e.g., cancer with reduced life expectancy)
  • abuse of drugs or alcohol
  • female study participants of child- bearing age without adequate contraception
  • women during pregnancy or lactation
  • no sufficient knowledge of the German language to answer the questionnaires
  • other surgical contraindications
  • participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology and Neurosurgery

Berlin, Germany

Location

Related Publications (1)

  • Giladi N, Tal J, Azulay T, Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe WH, Stocchi F, Tolosa E. Validation of the freezing of gait questionnaire in patients with Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):655-61. doi: 10.1002/mds.21745.

    PMID: 19127595BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseMovement Disorders

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Andreas R Kupsch, MD

    Department of Neurology, Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 24, 2009

Study Start

July 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 22, 2009

Record last verified: 2009-07

Locations

DE(1)