Effects of Deep Brain Stimulation in Parkinson's Disease
NCT ID: NCT00855621
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2009-03-31
2023-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Single microelectrode
Surgical procedure performed using single microelectrode recording guidance intraoperatively
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.
Multiple microelectrode
Surgical procedure performed using multiple microelectrode recording guidance intraoperatively
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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South-Eastern Norway Regional Health Authority
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Mathias Toft
Consultant neurologist
Principal Investigators
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Espen Dietrichs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, Oslo County, Norway
Countries
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References
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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.
Other Identifiers
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RRHF-PD-01
Identifier Type: -
Identifier Source: org_study_id