The aim of the study is to gain insight on the somatotopy of the subthalamic nucleus. The relation between the postion o fthe electrode in the STN, the parameter settings of the stimulator and the effectiveness of the stimulation on Parkinson's…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study is designed to measure tremor, bradykinesia/akinesia and speech
dificiencies in Parkinson's disease. These factors can than be related to the
position of the electrode which is determined from preoperative MRI scans or
post-operative CT scans.
Secondary outcome
n.a.
Background summary
Deep brain stimulation (DBS) is a widely used method for the elevation of the
symptoms of Parkinson Disease. The functional mechanisms of the study are
however not completely known yet. There is also only little known about
influence of the parameter settings in relation to the position of the
electrode in the subthalamic nucleus (STN) on Parkinson's disease. In this
study the influence of the stimulation of specific areas in the STN is
determined. We hope to gain more insight in the functional mechanisms of DBS in
Parkinson patients, in order to increase the effectiveness of the therapy.
Study objective
The aim of the study is to gain insight on the somatotopy of the subthalamic
nucleus. The relation between the postion o fthe electrode in the STN, the
parameter settings of the stimulator and the effectiveness of the stimulation
on Parkinson's disease is determined. The experiments are performed using
inertial sensors on different body parts, arms and legs. The effect of deep
brain stimulation on different parts of the body is examined. The position of
the electrode is determined from available scans (MRI / CT). The experiments
are than used to relate the position of the electrode to the effectiveness of
the stimulation and the parameter settings.
Study design
Patient experiments are performed, using inertial sensors and EMG measurements
on arms and legs, to measure the effectiveness of the stimulation under
different stimulator settings.
In this study a group of Parkinson patients with an STN stimulator is asked to
participate. Four different settings of the stimulator are used, in order to
determine the influence of the stimulator on the symptoms of Parkinson disease.
The influence is measured separately for arms and legs and left and right side,
whereby the patients is asked to perform 3 simple movement tasks. All patients
will perform the same experiments. The effectiveness will be determined using
the tremor, bradykinesia/akinesia and speech difficiencies.
Intervention
The intervention of this research project is based on influencing the
stimulator. The stimulator is adjusted to 4 different settings, of which 3 are
different than the original setting of the stimulator. The 3 different settings
comprise of: 1.) lowering the amplitude until tremor starts again, 2.)
switching off the stimulator and 3.) changing the stimulated electrode contact
and rising the amplitude until tremor has disappeared again.
Study burden and risks
Patients participating in the study will be asked to switch off the stimulator,
or change the parameter settings of the stimulator. This will have an effect on
the functioning of the stimulator. Patients may experience worsening of
symptoms during the measurement with the changed parameter settings. The
participants will need to spend a maximum of one and a half hours to complete
the whole study. After the experiments the stimulator settings are returned to
their original settings, so no permanent change in Parkinson symptoms is
expected. The participants will not directly benefit from the study, but the
study might help future patients to benefit more from their stimulator and to
find the optimal target for stimulation and the optimal stimulation settings.
Postbus 50.000
7500 KA Enschede
Nederland
Postbus 50.000
7500 KA Enschede
Nederland
Listed location countries
Age
Inclusion criteria
Patient suffers from Parkinson's disease
Patient has received bilateral DBS in the STN
Patient underwent surgery at least three month ago
Patient experiences a good clinical result from DBS
Patient has no major fluctuations in symptoms due to medication
Patient is in good physical condition
Patient responds within 5 minutes to changes in the stimulator settings
Exclusion criteria
Patient cannot fully cooperate with the experiments
Patient suffers from dementia
Patient suffers from severe dyskinesia/akinesia
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 | NL18696.044.07 |