Deep Brain Stimulation (DBS) For Parkinson's Disease: Caudal Zona Incerta Versus Subthalamic Nucleus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Charite University, Berlin, Germany.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00888095
First received: April 23, 2009
Last updated: July 21, 2009
Last verified: July 2009

April 23, 2009
July 21, 2009
July 2010
July 2013   (final data collection date for primary outcome measure)
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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00888095 on ClinicalTrials.gov Archive Site
Changes in dysarthria, other symptoms (subitems of UPDRS-III), dyskinesia (UPDRS-IV), impairment of gait, on-off fluctuations [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Deep Brain Stimulation (DBS) For Parkinson's Disease: Caudal Zona Incerta Versus Subthalamic Nucleus
The Clinical Effect of Bilateral Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) Versus Bilateral Deep Brain Stimulation of the Caudal Zona Incerta (cZI-DBS) in Patients With Idiopathic Parkinson's Disease

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.

Parkinson's Disease (PD) is a severe neurological movement disorder comprising the triad of symptoms of bradykinesia, rigidity and tremor. It can be effectively treated with dopaminergic replacement therapy in the early course of the disease; however, after 5-10 years medical therapy is insufficient in the majority of patients. Since the early 90s the implantation of electrodes into the Nucleus subthalamicus (STN), (deep brain stimulation; DBS) has been established. DBS in PD- patients provides a definite and longlasting relief of motor symptoms and impaired quality of life compared to optimized medical treatment (Deuschl et al. 2006). Conventionally, electrodes are implanted into STN but other targets such as the pedunculopontine nucleus or the Zona incerta (ZI) have been reported to be useful. Importantly, the ZI has a key role in connection loops from the basal ganglia, thalamic regions and cortex. Retrospective studies of DBS-treated patients show relief of symptoms in DBS- treated PD patients, with the contacts of the electrodes being located to the ZI (Voges et al., 2002; Hamel et al., 2003a, 2003b). However, no prospective randomized studies analysing the effect of bilateral DBS comparing the targets of the caudal ZI (cZI) and STN are available. Therefore, the present study will investigate the effect and tolerance of DBS in both targets in a blind, randomized and stratified design in a total of 70 PD patients (see below for inclusion end exclusion criteria). The impairment of movement and quality of life will be assessed via established scales. Effects, tolerance and side effects of DBS will be monitored closely and re-assessed for a period of twelve months. Primary study criteria include UPDRS-III and quality of life.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Parkinson's Disease
Procedure: deep brain stimulation
electrode implantation in either STN or cZI
  • Experimental: 1
    caudal Zona incerta (cZI)
    Intervention: Procedure: deep brain stimulation
  • Experimental: 2
    Nucleus subthalamicus (STN)
    Intervention: Procedure: deep brain stimulation
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 Jan 6; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • major depression with suicidal thoughts (Becks Depressions Inventory-Score > 25); depressions in the past are no exclusion criterion
  • Mattis Dementia Rating Scale-score < 130
  • stereotactic brain operations in the past
  • significant brain atrophy
  • increased bleeding tendency
  • reduced infection defense
  • relevant cerebrovascular disease
  • acute psychosis (benign and/or hallucinations in the past are no exclusion criterion)
  • 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
Both
18 Years to 75 Years
No
Not Provided
Germany
 
NCT00888095
DBS in the caudal Zona incerta
Yes
Prof. Dr. A. Kupsch, Department of Neurology
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Andreas R Kupsch, MD Department of Neurology, Charité
Charite University, Berlin, Germany
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP