Randomized trial comparing steered Deep Brain Stimulation with ring-shaped Deep Brain Stimulation for advanced Parkinson*s disease
Phase 4
Recruiting
- Conditions
- ParkinsonParkinson's disease10028037
- Registration Number
- NL-OMON53065
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is a score of motor symptoms in daily living as<br /><br>expressed in the Movement Disorders Society Unified Parkinson Disease Rating<br /><br>(MDS-UPDRS) motor evaluation in standardized OFF-drug phase. This score is<br /><br>measured in the total of all patients included, the subgroup of patients whose<br /><br>ring-mode stimulation has yielded a suboptimal effect (as evaluated by the<br /><br>patients* physician) and the subgroup of patients whose ring-mode stimulation<br /><br>has yielded a good effect (as evaluated by the patients* physician).The<br /><br>combined subgroups form the total of all included patients. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome consists of symptom scales, percentage of patients with great<br /><br>symptom improvement (an MDS-UPDRS score in OFF-phase of 30% or greater), used<br /><br>stimulation settings, medication use, stimulation-induced side-effects,<br /><br>activities of daily living scales and a quality of life questionnaire. At the<br /><br>end of the trial, patients will be asked to choose between the two used<br /><br>programs to evaluate, which one was perceived as the best. A sub-analysis will<br /><br>be performed to evaluate whether good DBS responders and suboptimal DBS<br /><br>responders score differently on primary and secondary endpoints.</p><br>