By pre-operatively visualizing the thalamus of DBS patients with epilepsy using 7T MRI, we aim to locate clinically effective and ineffective electrode placement relative to the thalamic subnuclei and its connectivity.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main radiological endpoint will be the location of the DBS electrode within
the thalamic subnuclei and its structural and functional connectivity. De study
parameters used are the DBS electrode contact coordinates (in y, x and z
directions) and Euclidean distance of the implanted DBS electrode to the
thalamic subnuclei defined by segmentation and by structural and functional
MRI. The main clinical endpoint will be the reduction in seizure frequency
after DBS.
Secondary outcome
not applicable
Background summary
Deep brain stimulation (DBS) of the thalamus can be an effective therapy for
patients with drug-resistant epilepsy who do not qualify for resective epilepsy
surgery. However, DBS responder rates vary, possibly due to suboptimal
placement of the DBS electrode related to poor visualization of the thalamic
subnuclei at low-field strength (1.5T and 3T) MRI. More accurate visualization
of the thalamus with ultra-high field (7T) MRI may very likely improve lead
placement in the future and thus therapy response. By pre-operatively
visualizing the thalamus of DBS patients with epilepsy using 7T MRI, we aim to
compare electrode placement and its connectivity between responders and
non-responders to DBS.
Study objective
By pre-operatively visualizing the thalamus of DBS patients with epilepsy using
7T MRI, we aim to locate clinically effective and ineffective electrode
placement relative to the thalamic subnuclei and its connectivity.
Study design
We will use a prospective observational study design to compare DBS electrode
placement in the thalamus and its connectivity in responders and non responders
to DBS for epilepsy.
Study burden and risks
There are no additional risks associated with a 7T MRI scan compared to
standard 3T MRI scan for participants in this study if contra-indications are
taken heed of. A small number of people (~5%) may experience temporary vertigo,
nausea, metallic taste or tingling sensations while entering the scanner.
Universiteitsssingel 50
Maastricht 6229 ER
NL
Universiteitsssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
All subjects must be mentally competent (wilsbekwaam) and able to understand the patient information form and decide for participation.
All subjects must be aged over 18 years old.
All subjects must meet all inclusion requirements of the standard Scannexus screening form
All subject must be included for DBS surgery at the MUMC+ for treatment of drug-resistant epilepsy
Exclusion criteria
Neurological diseases other than epilepsy, such as brain tumours, stroke, severe neurotrauma*s, and neurodegenerative diseases.
Foreign ferromagnetic objects in the subject*s body or other contra indications for MRI. Prior to scanning, subjects will fill out a screening form. This form will be sent with the information letter to all subjects (Appendices 4 and 5). The screening form will be filled out again on the day of the scan, 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 | NL66101.068.18 |