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

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ClinicalTrials.gov Identifier: NCT00888095
Recruitment Status : Unknown
Verified July 2009 by Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2009
Last Update Posted : July 22, 2009
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: deep brain stimulation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
caudal Zona incerta (cZI)
Procedure: deep brain stimulation
electrode implantation in either STN or cZI

Experimental: 2
Nucleus subthalamicus (STN)
Procedure: deep brain stimulation
electrode implantation in either STN or cZI

Primary Outcome Measures :
  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 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Changes in dysarthria, other symptoms (subitems of UPDRS-III), dyskinesia (UPDRS-IV), impairment of gait, on-off fluctuations [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888095

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Department of Neurology and Neurosurgery
Berlin, Germany
Contact: Andreas R Kupsch, MD    xx49-30-450-50 ext 660103    andreas.kupsch@charite.de   
Contact: Andrea A Kühn, MD    xx49-30-450-50 ext 660203    andrea.kuehn@charite.de   
Principal Investigator: Andreas R Kupsch, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Andreas R Kupsch, MD Department of Neurology, Charité
Additional Information:
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Responsible Party: Prof. Dr. A. Kupsch, Department of Neurology
ClinicalTrials.gov Identifier: NCT00888095    
Other Study ID Numbers: DBS in the caudal Zona incerta
First Posted: April 24, 2009    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009
Keywords provided by Charite University, Berlin, Germany:
deep brain stimulation
caudal Zona incerta
Nucleus subthalamicus
Parkinson's disease
Movement disorder
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases