We hypothesize that bilateral globus pallidus internus (GPi) DBS produces greater functional improvement in PD than bilateral STN DBS because of a lower rate of complications.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Baseline and outcome measurements at 12 months will be done in standardized off
and on phases. The primary outcome measures are the Neuropsychiatric Inventory
(cognition, mood, and behavior) and the off-on phase weighted AMC Linear
Disability Scale (functional improvement).
Secondary outcome
Secondary outcome consists of symptom scales, activities of daily living
scales, a quality of life questionnaire, adverse effects, and medication use.
Additionally, patients will undergo extensive neuropsychological assessment.
Background summary
Patients with advanced Parkinson*s disease (PD) and long-term pharmacologic
treatment often have response fluctuations and involuntary movements
(dyskinesias). Frequently they cycle between episodes with Parkinsonism
associated with severe disability (*off* phase) and episodes with good mobility
(*on* phase), usually with dyskinesias. Continuous bilateral subthalamic
nucleus (STN) deep brain stimulation (DBS) is an effective surgical treatment
for patients with advanced PD who have severe limitations in functioning
despite optimal pharmacologic treatment. Recently however, the concerns about
STN DBS and adverse effects are increasing, especially for the cognitive, mood,
and behavioral features.
Study objective
We hypothesize that bilateral globus pallidus internus (GPi) DBS produces
greater functional improvement in PD than bilateral STN DBS because of a lower
rate of complications.
Study design
The study will be a randomized, multi-center, double-blind trial comparing
continuous bilateral GPi DBS with bilateral STN DBS in advanced PD.
Intervention
A neurosurgical procedure using stereotactic techniques will be employed for
implantation of two electrodes with the functional contact at both subthalamic
nuclei or both globus pallidus. The electrodes will be connected to an
implantable pulse generator under general anesthesia. Patients will regularly
visit a neurologist at the outpatient clinic to adjust stimulation parameters
and PD medication while assessing the interaction between both treatments.
Study burden and risks
At baseline and 12 months follow-up, patients will be assessed in standardized
off and on phases, which include withholding PD medication for 12 h and a
hospital visit (3 h). Patients will complete a diary for three days.
Additionally, an extensive neuropsychological evaluation in the on phase will
be performed (3 h). If the study shows that bilateral DBS of the GPi produces
greater functional improvement than bilateral STN DBS, then this will have a
major impact on the current practice.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Inclusion criteria are idiopathic Parkinson's disease and * despite optimal pharmacological treatment * at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia.
Exclusion criteria
Exclusion criteria are: age below 18 years, previous functional stereotactic neurosurgery, Hoehn and Yahr stage 5 at the best moment during the day, a MATTIS dementia rating scale score of 120 or less, current psychosis or depression, and contraindications for stereotactic neurosurgery such as a physical disorder making surgery hazardous (severe hypertension, blood coagulation disorder, severe dysphagia, or dysarthria).
Design
Recruitment
Medical products/devices used
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 | NL11196.018.06 |