Clinical trial NCT00855621: Effects of Deep Brain Stimulation in Parkinson's Disease
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: deep brain stimulation
subthalamic nucleus
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2009-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline of Clinical Dyskinesia Rating Scale score
timeFrame: 12 months
measure: Change from baseline in ADL function (UPDRS part II)
timeFrame: 12 months
measure: Change from baseline in Mattis Dementia Rating Scale score
timeFrame: 12 months
measure: Change in social functioning (Social adjustment scale-SR)
timeFrame: 12 months
measure: Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)
timeFrame: 12 months
measure: Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)
timeFrame: 12 months
measure: Frequency of new or worsened psychiatric symptoms
timeFrame: 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Neurology, Oslo University Hospital
name: Espen Dietrichs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerknes S, Toft M, Konglund AE, Pham U, Waage TR, Pedersen L, Skjelland M, Haraldsen I, Andersson S, Dietrichs E, Skogseid IM. Multiple Microelectrode Recordings in STN-DBS Surgery for Parkinson's Disease: A Randomized Study. Mov Disord Clin Pract. 2018 May 8;5(3):296-305. doi: 10.1002/mdc3.12621. eCollection 2018 May-Jun.