Parkinson's DiseaseNCT00855621
Effects of Deep Brain Stimulation in Parkinson's Disease
A study testing Deep brain stimulation of the subthalamic nucleus in people with Parkinson's Disease, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Deep brain stimulation of the subthalamic nucleus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Increased risk of bleeding
- Presence of medical illness with short life expectancy
- Other surgical contra-indications
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Conditions
- Parkinson's Disease
- Being tested
- Deep brain stimulation of the subthalamic nucleus
- Keywords
- deep brain stimulation, subthalamic nucleus
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation of the subthalamic nucleusProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single microelectrode | Active comparator | Surgical procedure performed using single microelectrode recording guidance intraoperatively Receives: Procedure: Deep brain stimulation of the subthalamic nucleus |
| Multiple microelectrode | Active comparator | Surgical procedure performed using multiple microelectrode recording guidance intraoperatively Receives: Procedure: Deep brain stimulation of the subthalamic nucleus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
Measured: 12 months
Secondary outcomes (7)
Change from baseline of Clinical Dyskinesia Rating Scale score
Measured: 12 months
Change from baseline in ADL function (UPDRS part II)
Measured: 12 months
Change from baseline in Mattis Dementia Rating Scale score
Measured: 12 months
Change in social functioning (Social adjustment scale-SR)
Measured: 12 months
Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)
Measured: 12 months
Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)
Measured: 12 months
Frequency of new or worsened psychiatric symptoms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2014
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Mathias Toft, Oslo University Hospital
- Investigators
- Espen Dietrichs, MD, PhD, Principal investigator, Department of Neurology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855621
- Sponsor's protocol ID
- RRHF-PD-01
- Status last verified
- Nov 2016
- First submitted
- 3 Mar 2009
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30009214
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00855621
- Acronym / sponsor ID
- RRHF-PD-01
- Conditions
- Parkinson's Disease
- Keywords
- deep brain stimulation, subthalamic nucleus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- Mar 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single microelectrode | Active comparator | Procedure: Deep brain stimulation of the subthalamic nucleusSurgical procedure performed using single microelectrode recording guidance intraoperatively |
| Multiple microelectrode | Active comparator | Procedure: Deep brain stimulation of the subthalamic nucleusSurgical procedure performed using multiple microelectrode recording guidance intraoperatively |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep brain stimulation of the subthalamic nucleusChronic 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. | Procedure or surgery | Multiple microelectrode, Single microelectrode |
Primary outcome
Change from baseline of the motor score of the New-UPDRS (part III) OFF medication
Time frame: 12 months
7 secondary outcomes
Change from baseline of Clinical Dyskinesia Rating Scale score
Time frame: 12 months
Change from baseline in ADL function (UPDRS part II)
Time frame: 12 months
Change from baseline in Mattis Dementia Rating Scale score
Time frame: 12 months
Change in social functioning (Social adjustment scale-SR)
Time frame: 12 months
Change from baseline in caregivers quality of life (Scale of Caregivers Quality of Life)
Time frame: 12 months
Change from baseline of self-reported health-related quality of life (PDQ-39 Summary Index)
Time frame: 12 months
Frequency of new or worsened psychiatric symptoms
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Derived from this study: PubMed 30009214Bjerknes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Dietrichs, MD, PhD principal investigator
Department of Neurology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep brain stimulation of the subthalamic nucleus in people with Parkinson's Disease, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the motor score of the New-UPDRS (part III) OFF medication (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.