Trial record 12 of 128 for:    Deep Brain Stimulation for Parkinson's Disease

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
  Purpose

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 Intervention
Parkinson's Disease
Procedure: deep brain stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888095

Locations
Germany
Department of Neurology and Neurosurgery Not yet recruiting
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
Investigators
Principal Investigator: Andreas R Kupsch, MD Department of Neurology, Charité
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Dr. A. Kupsch, Department of Neurology
ClinicalTrials.gov Identifier: NCT00888095     History of Changes
Other Study ID Numbers: DBS in the caudal Zona incerta
Study First Received: April 23, 2009
Last Updated: July 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Charite University, Berlin, Germany:
deep brain stimulation
caudal Zona incerta
Nucleus subthalamicus
Parkinson's disease
randomized
blinded
Movement disorder

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 26, 2014