Effects of Deep Brain Stimulation in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Oslo University Hospital
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00855621
First received: March 3, 2009
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to identify factors predicting good results in patients treated with deep brain stimulation for Parkinson's disease. The study includes a comparison of two surgical methods used to provide this therapy.


Condition Intervention
Parkinson's Disease
Procedure: Deep brain stimulation of the subthalamic nucleus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prognostic Factors in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) - a Prospective Randomized Double-blind Study (The NORSTIM Study)

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Change from baseline of the motor score of the New-UPDRS (part III) OFF medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline of Clinical Dyskinesia Rating Scale score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in ADL function (UPDRS part II) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in Mattis Dementia Rating Scale score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Change in social functioning (Social adjustment scale-SR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency of new or worsened psychiatric symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2009
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single microelectrode
Surgical procedure performed using single microelectrode recording guidance intraoperatively
Procedure: Deep brain stimulation of the subthalamic nucleus
Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.
Active Comparator: Multiple microelectrode
Surgical procedure performed using multiple microelectrode recording guidance intraoperatively
Procedure: Deep brain stimulation of the subthalamic nucleus
Chronic bilateral deep brain stimulation in the nucleus subthalamicus is performed using the most effective of four electrode contacts identified during testing of stimulation settings. Stimulation settings will be variable and adjusted according to the symptoms of each individual patient. Stimulation parameters will be recorded at each individual examination. Dopaminergic and other necessary medication will be given according to the need of each patient.

Detailed Description:

The study will prospectively examine the effects of deep brain stimulation of the subthalamic nucleus (STN-DBS) on motor function, quality of life and cognitive function in Parkinson's disease (PD) patients treated at Rikshospitalet University Hospital. The aim is to identify which factors that predict good treatment outcome, in order to improve patient selection of this generally highly effective, but specialized and expensive treatment.

The study has several aims:

  1. Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement.
  2. To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus.
  3. To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus
  4. To study social functioning of patients after STN-DBS and quality of life of patient caregivers
  Eligibility

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

Inclusion Criteria:

  • Diagnosis of Parkinson's disease
  • Symptoms ≥ 5 years
  • Severity of Parkinson's disease ≥ 20 points in UPDRS motor scale (scale 0-108) in OFF medication state
  • Marked fluctuations of motor symptoms AND/OR troublesome dyskinesias AND/OR severe tremor AND/OR intolerable side-effects of dopaminergic drugs
  • Failure of medical treatment to sufficiently control symptoms
  • L-dopa responsive symptoms with ≥30% reduction in UPDRS motor score in drug ON state compared to OFF state OR severe l-dopa unresponsive tremor

Exclusion Criteria:

  • Previous surgery for Parkinson's disease
  • Marked axial motor symptoms unresponsive to treatment with l-dopa
  • Dementia (Mattis dementia rating scale < 130).
  • Patient suffering from untreated moderate or major depression or anxiety disorder
  • Presence of other psychiatric disorder preventing necessary co-operation
  • Brain MRI showing marked atrophy or white matter changes
  • Increased risk of bleeding
  • Presence of medical illness with short life expectancy
  • Other surgical contra-indications
  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: NCT00855621

Contacts
Contact: Mathias Toft, MD, PhD +4799514189 mathias.toft@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Mathias Toft, MD, PhD       mathias.toft@ous-hf.no   
Principal Investigator: Espen Dietrichs, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Espen Dietrichs, MD, PhD Department of Neurology, Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00855621     History of Changes
Other Study ID Numbers: RRHF-PD-01
Study First Received: March 3, 2009
Last Updated: September 17, 2012
Health Authority: Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
deep brain stimulation
subthalamic nucleus

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 September 22, 2014