To demonstrate that steered STN DBS is more effective than ring-mode DBS in reducing PD motor symptoms and to demonstrate that steered STN DBS has the potential to cause less stimulation-induces side-effects.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is a score of motor symptoms in daily living as
expressed in the Movement Disorders Society Unified Parkinson Disease Rating
(MDS-UPDRS) motor evaluation in standardized OFF-drug phase. This score is
measured in the total of all patients included, the subgroup of patients whose
ring-mode stimulation has yielded a suboptimal effect (as evaluated by the
patients* physician) and the subgroup of patients whose ring-mode stimulation
has yielded a good effect (as evaluated by the patients* physician).The
combined subgroups form the total of all included patients.
Secondary outcome
Secondary outcome consists of symptom scales, percentage of patients with great
symptom improvement (an MDS-UPDRS score in OFF-phase of 30% or greater), 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.
Background summary
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 caused by electrical current overspill into areas of
the brain adjacent to the target areas. Recently, new DBS electrodes have been
commercialized that claim to be able to achieve a certain degree of steering of
the stimulating electrical current (steering electrodes, as opposed to the
conventional ring-mode electrodes).
Study objective
To demonstrate that steered STN DBS is more effective than ring-mode DBS in
reducing PD motor symptoms and to demonstrate that steered STN DBS has the
potential to cause less stimulation-induces side-effects.
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.
Intervention
After a period of searching for the optimal steered mode settings, patients
will be randomized and blindly receive two different programming forms of DBS
stimulation: ring mode and steered mode during two consecutive periods of two
months each. The patient, the assessor and the investigator performing the
statistical analyses will be blind to the order in which the two settings are
administered. The patient*s physician may be unblinded if stimulation-related
problems occur.
Study burden and risks
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.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years
bilaterally implanted with the Boston Scientific or Medtronic 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 criteria
no 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
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61838.018.17 |