The current study aims to go further than the previous METC application of B. Plantinga (2014). In addition to providing optimized structural delineations of the STN via the increased contrast offered by 7T MRI, the existence of structural…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To create individualised, subject-specific connectivity profiles of STN
structure and function by combining DWI and rs-fMRI data; specifically, to
identify exclusive motor components of the STN.
Secondary outcome
To assess the quality differences across 3T and 7T MRI
To create anatomical atlases of the STN. These atlases aim to identify the
extent of individual variability, both in healthy brains and in PD. These
atlases will be created by combining individual manually segmented STNs from 7T
structural MRI.
To develop a prognostic model that can be used to determine whether PD patients
are suitable candidates for DBS. The prognostic model will be based on STN
anatomy (e.g. location and size), connectivity (structural and function),
pre-operative UPDRS scores, resultant DBS electrode placement and clinical
outcome.
Background summary
See introduction section of the METC (pages 9-14).
Study objective
The current study aims to go further than the previous METC application of B.
Plantinga (2014). In addition to providing optimized structural delineations of
the STN via the increased contrast offered by 7T MRI, the existence of
structural subdivisions within the STN will be assessed using
UHF DWI with additional resting-state functional MRI (rs-fMRI). It is likely
that STN subdivisions are better delineated based on both domain specific,
functional networks as well as direct, structural white matter tract
connections.
The combination of data from DWI and rs-fMRI images will allow for the creation
of individualised connectivity profiles for both PD patients and healthy
controls.
For PD patients, the resultant connectivity profiles may offer a selection of
potential coordinates that may be used as electrode targets for DBS surgeries.
Quantifying the structural and functional nature of the STN as well as surgical
outcomes may aid the development of a prognostic model which can be used to
better select suitable PD candidates for DBS in the future.
Additionally, STN segmentations will be used to create anatomical atlases in
both the healthy and diseased brain. Such atlases are essential for both
scientific research and for localization procedures in neurosurgery;
particularly in relation to acknowledging the extent of individual differences
in neuroanatomy.
Study design
observational cohort
Study burden and risks
All subjects, both patients and healthy, will be assessed in terms of their
suitability to participate in the research.
Only suitable subjects will be included for scanning. The burden for the
subjects, and in particular, the patients, rests with extended scanning time of
up to 60 minutes, which is substantially more than is currently required for
the standard medical procedures. However, a previous METC accepted study has
proved this is necessary to obtain optimal images and can produce valuable
information that cannot be obtained with the currently utilized clinical
techniques. Subjects will be given the choice of splitting the scan in to two
30 minute sessions. Scanning will in no way interfere with clinical treatment.
When attention is paid to the contra-indications for MRI, 7T MRI is harmless.
Patients may benefit from individualised and optimised treatment during this
study or in the future, as will other PD patients not included in the study.
There is no direct benefit of the healthy controls, other than knowing that
they will contribute to research regarding the structure and function of the
STN.
P. Debyelaan 25
Maastricht 6202AZ
NL
P. Debyelaan 25
Maastricht 6202AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for Parkinson's patients ;1. Patients must be mentally competent (Wilsbekwaam).;2. Patients must meet all requirements of the standard Scannexus screening form (see METC appendix).;3. Patients much be aged between 18 and 80 years old.;Inclusion criteria for Healthy Volunteers ;1. Healthy controls must be mentally competent (Wilsbekwaam).;2. Healthy controls must not be suffering from any neurological or psychiatric illnesses.;3. Healthy controls must meet all requirements of the standard Scannexus screening form (see METC appendix).;4. The age and gender of healthy control subjects should not significantly differ to the age and gender of the PD patients. ;5. Subjects must be aged between 18 and 80 years old.
Exclusion criteria
1. Former severe head injury requiring surgery.;2. Stroke.;3. Suffering from any other non-psychiatric brain diseases. ;4. Metallic prostheses or pacemaker in the subject*s body or other contra indications for MRI. Prior to scanning, subjects will fill out a screening form (see METC appendix). This form will be sent with the information letter to all subjects. An additional form will be filled out on the day of the scan. Both are to ensure any contra indications are known to both the subject and the scanning technician.
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 | NL60342.068.17 |