The design of an ambulant system that is capable of long-term estimation of the right UPDRS-levels for tremor, bradykinesia, and akinesia in patients with Parkinson*s disease receiving deep brain stimulation in the subthalamic nucleus using a…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters (obtained from the inertial sensors) relating to the UPDRS-scores
for tremor, bradykinesia, and akinesia during three conditions are compared.
These conditions are stimulator on with normal settings, stimulator on with
altered settings, and stimulator off.
The correlations of these parameters to the UPDRS-scores of tremor,
bradykinesia, and akinesia is also assessed.
Secondary outcome
not applicable
Background summary
Deep brain stimulation is an effective method to suppress symptoms relating to
Parkinson*s disease. However, improvements are always possible. To make deep
brain stimulation even more effective, it is necessary to adjust the settings
of the stimulator in the most optimal way. Nowadays, the deep brain stimulator
is adjusted subjectively by the specialist based on observations over short
periods.
During this research, the possibilities for developing an objective ambulant
system, which is capable of quantifying movement disturbances over long-term,
are assessed. Eventually, the system should be able to quantify tremor,
bradykinsia, and akinesia in such a way that different settings of the deep
brain stimulator can be discriminated. In this way, the deep brain stimulator
can be adjusted optimally, making the treatment more effective.
Study objective
The design of an ambulant system that is capable of long-term estimation of the
right UPDRS-levels for tremor, bradykinesia, and akinesia in patients with
Parkinson*s disease receiving deep brain stimulation in the subthalamic nucleus
using a minimal number of kinematic sensors. The system should be sensitive
enough to detect differences in UPDRS-levels at different settings of the
stimulator.
Study design
Observational, non-invasive research.
Study burden and risks
The extent of the burden is a measurement taking maximally one and a half hour,
performed at the *Medisch Spectrum Twente*. During the measurements, five
inertial sensors will be attached to the body using dermatologic tested tape on
the sternum, the wrist and the thigh of the most affected side, and both
shanks. In addition, the stimulator will be turned off and the settings of the
stimulator will be altered, both for a maximal period of 20 minutes. During the
measurements, the subject is asked to perform some small movement tasks. A
large part of these tasks is part of the UPDRS-test. This test and the turning
off and change of settings of the stimulator are also performed during regular
visits to the specialist.
Postbus 50000
7500 KA Enschede
Nederland
Postbus 50000
7500 KA Enschede
Nederland
Listed location countries
Age
Inclusion criteria
- Parkinson patients having a deep brain stimulator in the subthalamic nucleus
- Patients experiencing a good clinical result from DBS
- Patients having no major fluctuations in symptoms due to medication
- Patients being in good physical condition
- Patients responding within 5 minutes to changes in the stimulator settings
Exclusion criteria
- Patients not being able to fully cooperate with 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 | NL18703.044.07 |