Effects of Deep Brain Stimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00855621
• Other study ID #: RRHF-PD-01
• Status: Active, not recruiting
• Phase: N/A
• First received: March 3, 2009
• Last updated: November 18, 2016
• Start date: March 2009
• Est. completion date: December 2023

Study information

• Verified date: November 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2023
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the motor score of the New-UPDRS (part III) OFF medication		12 months	No
Secondary	Change from baseline of Clinical Dyskinesia Rating Scale score		12 months	No
Secondary	Change from baseline in ADL function (UPDRS part II)		12 months	No
Secondary	Change from baseline in Mattis Dementia Rating Scale score		12 months	Yes
Secondary	Change in social functioning (Social adjustment scale-SR)		12 months	No
Secondary	Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)		12 months	No
Secondary	Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)		12 months	No
Secondary	Frequency of new or worsened psychiatric symptoms		12 months	Yes