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Randomized trial comparing steered stimulation DBS with ring-shaped DBS for advanced Parkinson’s disease


- candidate number27453
- NTR NumberNTR6696
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jun-2017
- Secondary IDs2017_164 METC Amsterdam
- Public TitleRandomized trial comparing steered stimulation DBS with ring-shaped DBS for advanced Parkinson’s disease
- Scientific TitleRandomized trial comparing steered stimulation DBS with ring-shaped DBS for advanced Parkinson’s disease
- ACRONYMSTEEred vs RING-mode DBS for Parkinson’s disease (STEERING) trial
- hypothesisWe hypothesize that steering DBS will lead to a greater reduction of PD motor symptoms than ring-mode DBS. We will also separately measure the effect of the two types of DBS in people who have good response to ring-mode and those who don’t.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Deep Brain Stimulation (DBS), Subthalamic nucleus (STN)
- Inclusion criteriaAge ≥ 18 years
bilaterally implanted with the Boston Scientific® Vercise™ system in the STN for idiopathic Parkinson’s Disease at least 6 months previous to study enrollment
the optimal ring-mode stimulation setting has been found for the patient: changing settings will either (a) not improve the motor scores or (b) cause stimulation-induced side-effects
Patients who have received this system by participating in the GALAXY-trial can only be randomized after completion of the GALAXY trial.
- Exclusion criteriano adequate stimulation response in ring-mode on one of the steerable levels (second and third contact point on each lead)
Legally incompetent adults
Active psychosis
No written informed consent
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- control[default]
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2017
- planned closingdate1-okt-2020
- Target number of participants102
- InterventionsAfter a period of searching for the optimal steered mode settings, patients will be randomized to receive both steered and ring-mode stimulation in consecutive periods of two months in random order. The patient, the assessor and the investigator performing the statistical analyses will be blind to the order in which the two settings are administered.
- Primary outcomeWe will evaluate the difference of motor symptoms in patients with steered and ring-mode DBS in standardized OFF-drug phase measured with the Movement Disorders Society Unified Parkinson Disease Rating Scale motor evaluation (MDS-UPDRS-ME).
- Secondary outcomeSecondary outcome consists of symptom scales, used stimulation settings, medication use, stimulation-induced side-effects, activities of daily living scales and a quality of life questionnaire. At the end of the trial, patients will be asked to choose between the two used programs to evaluate which one was perceived as the best. A sub-analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.
- Timepoints• (informed consent)
• Baseline
• Visites tijdens instelperiode van “steering-settings”
• Randomisatievisite
• Cross-over visite
• Release visite
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. T.R. ten Brinke
- CONTACT for SCIENTIFIC QUERIESDrs. T.R. ten Brinke
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center Amsterdam, innovation grant
- Publications
- Brief summaryRationale: Continuous bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) is an effective surgical treatment for patients with advanced Parkinson’s Disease (PD) who have severe limitations in functioning due to medication induced motor response fluctuations. Despite its effectiveness, DBS therapy is oftentimes restricted by side-effects, possibly caused by electrical current overspill into areas of the brain adjacent to the target areas. Recently, new DBS electrodes have been developed that claim to be able to achieve a certain degree of steering of the electrical current (steering electrodes, as opposed to the conventional ring-mode electrodes).
Objective: To evaluate whether steered STN DBS is more effective than ring-mode DBS in reducing PD motor symptoms and to investigate if steered STN DBS has the potential to cause less stimulation-induces side-effects.
Hypothesis: We hypothesize that steering DBS will lead to a greater reduction of PD motor symptoms than ring-mode DBS. We will also separately measure the effect of the two types of DBS in people who have good response to ring-mode and those who don’t.
Study design: The study will be a randomized single-center prospective double-blind, crossover trial comparing two forms of STN deep brain stimulation settings: (1) ring-mode stimulation and (2) steered stimulation. A total of 102 patients will be included.
Study population: Patients with advanced PD who have been bilaterally implanted with Boston® Vercise™ DBS electrodes in the subthalamic nucleus in the AMC.
Intervention: After a period of searching for the optimal steered mode settings, patients will be randomized to receive both steered and ring-mode stimulation in consecutive periods of two months in random order. The patient, the assessor and the investigator performing the statistical analyses will be blind to the order in which the two settings are administered.
Main study parameters/endpoints: We will evaluate the difference of motor symptoms in patients with steered and ring-mode DBS in standardized OFF-drug phase measured with the Movement Disorders Society Unified Parkinson Disease Rating Scale motor evaluation (MDS-UPDRS-ME). Secondary outcome consists of symptom scales, used stimulation settings, medication use, stimulation-induced side-effects, activities of daily living scales and a quality of life questionnaire. At the end of the trial, patients will be asked to choose between the two used programs to evaluate which one was perceived as the best. A sub-analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will contribute to the optimization of DBS treatment with devices that allow for current steering. The hardware and software that will be used in the course of the study are CE approved, and DBS has been a registered therapy for PD for years. In this study, new programming options will be explored, which will extend the device programming time. There is a small chance/risk that the steering DBS form will have less benefit to the patient’s motor score when compared to ring-mode DBS or that patients will be subjected to a longer programming time with no additional clinical benefit. Participation in this study constitutes a negligible risk according to the NFU-criteria for human research.
- Main changes (audit trail)
- RECORD23-jun-2017 - 30-sep-2017


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