Effects of Deep Brain Stimulation in Parkinson's Disease

November 18, 2016 updated by: Mathias Toft, Oslo University Hospital

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

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

  • Norway
      • Oslo, Norway, 0027
        • Oslo University Hospital

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:

  • 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

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of Clinical Dyskinesia Rating Scale score
Time Frame: 12 months
12 months
Change from baseline in ADL function (UPDRS part II)
Time Frame: 12 months
12 months
Change from baseline in Mattis Dementia Rating Scale score
Time Frame: 12 months
12 months
Change in social functioning (Social adjustment scale-SR)
Time Frame: 12 months
12 months
Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)
Time Frame: 12 months
12 months
Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)
Time Frame: 12 months
12 months
Frequency of new or worsened psychiatric symptoms
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Espen Dietrichs, MD, PhD, Department of Neurology, Oslo University Hospital

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

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

March 1, 2009

Primary Completion (ACTUAL)

November 1, 2014

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (ESTIMATE)

March 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRHF-PD-01

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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