The primary objective is to assess the structural and functional segregation of the STN into its motor and non-motor regions in PD patients and healthy controls.The secondary objectives are:1. To compare the strength of the functional and structural…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint will be the structural and functional partition of the
STN into its motor and non-motor regions in PD patients and healthy controls.
Secondary outcome
The secondary study parameters are:
1. The strength of the functional and structural connectivity between the STN
and the motor and non-motor cortical areas in PD patients and controls.
2. The brain areas that show a significantly stronger or weaker functional or
structural connectivity from the STN to the motor or limbic cortical areas or
vice versa in PD patients than in controls.
3. The brain areas structurally and functionally connected to the stimulation
zone of the optimal electrode (only in patients).
4. Brain areas that show an activation related to the fMRI task.
5. The brain areas that show significantly more or significantly less
activation during the task fMRI in PD patients than in healthy subjects.
6. The deviation between the computed STN motor area (with 7T MRI) and the
surgically determined optimal electrode location.
7. The deviation between the pre-surgically determined target location with 3T
MRI (current clinical practice) and the surgically determined optimal electrode
location.
Background summary
Parkinson disease (PD) is a common neurodegenerative disorder characterized by
motor symptoms and also non-motor symptoms. Patients are initially treated
successfully with drugs, but prolonged drug use is limited due to dyskinesias,
motor fluctuations and debilitating side effects. In these advanced stages of
PD, deep brain stimulation (DBS) of the subthalamic nucleus (STN) (which
involves the placement of an electrode in the deeply situated STN) is the next
therapeutic option. Multiple long-term follow-up studies have demonstrated long
lasting beneficial effects on the motor function of PD patients due to STN DBS.
However, there are two major drawbacks. One is the induction of psychiatric
side-effects, which are expected to be caused by stimulation of the non-motor
territories of the STN. And the other is the long duration of the surgery;
because the STN and its subregions cannot be detected precisely on conventional
images, the patients need to be tested extensively intra-operatively to find
the right spot.
So in order to decrease side-effects and shorten the duration of the surgery,
accurate imaging of the STN and its subregions is required. It is expected that
at 7T MRI, the contrast and anatomic delineation of the STN improve greatly
compared to convectional imaging (1.5T or 3T MRI). Furthermore, with the use of
functional and diffusion MRI sequences, connections between cortical regions
and deep brain structures, which are expected to reveal information on the
segregation of the STN, can be investigated.
Therefore, we propose a set of experiments to test the hypothesis that with
ultra high field structural, functional and diffusion MRI we will be able to
identify the STN and its functional subterritories in PD patients and age- and
sex-matched control subjects. In the end this might serve to improve targeting
of the motor-part of the STN and decrease surgery time.
Study objective
The primary objective is to assess the structural and functional segregation of
the STN into its motor and non-motor regions in PD patients and healthy
controls.
The secondary objectives are:
1. To compare the strength of the functional and structural connectivity
between the STN and the motor and non-motor cortical areas between PD patients
and controls.
2. To compare the brain areas structurally and functionally connected to the
STN with the brain areas structurally and functionally connected to the
stimulation electrode in implanted PD patients.
3. To assess the difference between the brain activation pattern during the
task fMRI between PD patients and healthy controls.
4. To compare the final optimal electrode location as established during
surgery, to the STN motor area as determined with our methods (based on 7T MRI)
and to the pre-operatively defined target (based on 1.5T or 3T MRI) according
to current clinical protocol.
*
Study design
The study will be an observational study that investigates and compares the
structural and functional connectivity of the subthalamic nucleus in 35 PD
patients who are eligible for DBS surgery, 10 PD patients who are not eligible
for DBS surgery, and 10 healthy controls. The experiment consists of a one hour
7T MRI scan that subjects will undergo.
Study burden and risks
The burden consists of an investment of 90 minutes of time and a slight risk of
discomfort during scanning, mainly during entry or exit of the bore.
P.Debeylaan 25
Maastricht 6202AZ
NL
P.Debeylaan 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
For all groups:
1. Subjects must be mentally competent;For group 1 (PD patients scheduled for DBS surgery):
1. Patients suffering from Parkinson's disease who are eligible for deep brain stimulation surgery.;For group 2 (PD patients not scheduled for DBS surgery):
1. Diagnosis of idiopathic PD according to the UK Brain Bank Criteria
2. Excellent levodopa response
3. Disease course of > 3 years;For the healthy controls only:
1. Healthy volunteers with the same age and gender distribution as both patient populations.
Exclusion criteria
For all groups:
1. Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI.
2. Any neurological disease (other than PD).;For group 1 (PD patients scheduled for DBS surgery):
1. Any neurological or psychiatric disease other than PD.;For group 2 (PD patients not scheduled for DBS surgery)
1. Any neurological or psychiatric disease other than PD.;For healthy volunteers:
1. Any neurological or psychiatric disease.
2. The use of medication affecting the central nervous system.
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 | NL42613.068.13 |