The aim of this study is to determine objectively and quantitatively the relationship between different stimulation settings, in different nuclei (the subthalamic nucleus (STN) and the internal segment of the globus pallidus (GPi)) and the degree of…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During the study the following experiments will be conducted:
akinesia: reactiontime
bradykinesia: time of movement
rigidity: momentum on the elbow and knee joint during
passive movement
tremor: amplitude and frequency
muscle contractions: amplitude, degree of occurence and correlation with
stimulationsignal
dysarthria: amplitude, fluency and frequency
These parameters will be measured in total at sixteen different stimulator
settings namely; three amplitude settings for five different frequency settings
(15 in total) and one stimulator off condition. This research has been split up
into three segments per group to minimize the stress upon one patient. This
means that one patient undergoes six different stimulator settings, see
protocol pages 10 and 11.
Eventually the degree of influence of, and the relationship between, the
different settings concerning the surpression of the different Parkinsonian
symptoms will be analyzed.
Secondary outcome
not applicable.
Background summary
Deep brain stimulation (DBS) is widely used as an effective method to reduce
the utterance of Parkinson*s disease (PD) symptoms. However, the principle
mechanism(s) of action are still poorly understood. To be able to increase the
effectiveness of DBS for PD patients it is necessary to increase insight in the
mechanisms of action of DBS by PD patients. By an increase in the insight into
this mechanism of action it becomes possible to adjust the stimulator settings
to an optimal state for PD patients in a shortened period of time in an
objective manner. For now the stimulator settings are determined in a
subjective manner by the specialist.
Study objective
The aim of this study is to determine objectively and quantitatively the
relationship between different stimulation settings, in different nuclei (the
subthalamic nucleus (STN) and the internal segment of the globus pallidus
(GPi)) and the degree of utterance of PD symptoms.
Study design
Observational, non-invasive study, three way mixed design.
Study burden and risks
During this study the settings of the DBS stimulator will be changed six times
for short periods of time. One of the settings is that the stimulator is
switched off.
During these periods the following measurements will take place: reactiontime,
time of movement, rigidity (by determining the momentum upon the elbow and knee
joint during passive movement), tremor (by inertial sensors), involuntary
muscle contractions (by EMG) and dysarthria (by soundrecordings of a read out
text). In addition the patient will be asked some disease related questions.
There are no or negligible risks for the patient concerning this study. During
this study the stimulator settings will be changed for a short period of time,
from which one setting is with the stimulator switched off. Changing the
stimulator settings, however, also occurs during regular visits. At the end of
the experiments the initial settings of the patients stimulator will be
restored.
postbus 50000
7500 KA Enschede
NL
postbus 50000
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
- Parkinson patients receiving DBS in the STN or GPi
- Patients underwent surgery at least three month ago
- Patients experiencing good clinical results from DBS
- Patients do not experience major fluctuations in symptoms due to medication
- Patients are in good physical condition
- Patients responding within 5 minutes to changes in the stimulator settings
Exclusion criteria
- Patients who cannot fully cooperate during the experiments
- Patients suffering from dementia
- Patients suffering from severe dyskinesia
Design
Recruitment
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 | NL20294.044.07 |