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

July 21, 2009 updated by: Charite University, Berlin, Germany

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Department of Neurology and Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in dysarthria, other symptoms (subitems of UPDRS-III), dyskinesia (UPDRS-IV), impairment of gait, on-off fluctuations
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Andreas R Kupsch, MD, Department of Neurology, Charité

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

April 23, 2009

First Submitted That Met QC Criteria

April 23, 2009

First Posted (Estimate)

April 24, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2009

Last Update Submitted That Met QC Criteria

July 21, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBS in the caudal Zona incerta

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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