Trial record 6 of 99 for:
Deep Brain Stimulation for Parkinson's Disease
Effects of Deep Brain Stimulation in Parkinson's Disease
This study is currently recruiting participants.
Verified September 2012 by Oslo University Hospital
Sponsor:
Oslo University Hospital
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
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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:
- Randomized double-blind evaluation of the impact of using single vs. multiple electrode-recordings to guide electrode placement.
- To identify factors predicting good effect on motor function and improvements of quality of life after deep brain stimulation of the subthalamic nucleus.
- To identify cognitive and psychiatric changes related to deep brain stimulation of the subthalamic nucleus
- 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
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 May 19, 2013