The primary purpose of this study is to improve detection rate of (small) structural brain lesions by using ultra high field MRI in patients with focal drug-resistant epilepsy, and to use this information to improve seizure outcome one year after…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: the proportion of patients in whom apparent structural brain
lesions are detected on ultra high field MRI. Postoperative seizure outcome one
year after resective epilepsy surgery (Engel/ILAE class).
Secondary outcome
Secondary endpoints:
1. Differences between the ROI as previous determined in the non- or
semi-invasive workup, and the contralateral (non-epileptic) side.
2. Association between suspected ROI in the non- or semi-invasive workup and
the ultra high field MRI data.
3. Histopathological diagnosis of surgical specimen
4. Differences in ultra high field MRI performed in the same patient
Background summary
The prevalence of epilepsy is reported to be between 5 to 8 per 1,000
inhabitants, with a cumulative risk of having epilepsy somewhere during life of
3%. Based on seizure type, at least 61% of these patients are suffering from
localisation related epilepsies (Browne, 2000). Many patients still have no
lesion visible on the conventional MRI (3-Tesla) as a possible cause for their
epilepsy. In children with epilepsy this is about one-third (Reijs, 2007). The
study hypothesis is that the use of higher field strength MRI-scanners will
improve the detection of (small) structural brain lesions in patients with
focal drug-resistant epilepsy, potentially resulting in better seizure outcome
after resective epilepsy surgery.
Study objective
The primary purpose of this study is to improve detection rate of (small)
structural brain lesions by using ultra high field MRI in patients with focal
drug-resistant epilepsy, and to use this information to improve seizure outcome
one year after epilepsy surgery (Engel/ILAE class).
Secondary purposes are:
1. to compare suspected regions of interest (ROI) in the suspected hemisphere
in the non- or semi-invasive workup to the contralateral side.
2. to assess associations between suspected regions of interest (ROI) in the
non- or semi-invasive workup and ultra high field MRI data.
3. to assess associations between ultra high field MRI abnormalities,
histopathology and postoperative seizure outcome.
4. comparison of 2 ultra high field MRI*s in the same patient
Separately, a research protocol is prepared to study 9.4T MRI results of in
vivo ROI*s in a selected group of patients and compare this with surgically
removed lesions.
Study design
prospective, longitudinal, therapeutic study
Study burden and risks
Burden: One visit to the ultra high field-MRI-unit of Scannexus, Maastricht
(two visits for 10 patients). 60 Minutes of MRI-acquisition.
Participating in this study can improve surgical intervention and improve
chances of seizure outcome/freedom, especially in children.
If abnormalities are found in epilepsy surgery candidates, the information will
be passed on to the epilepsy surgery workgroup. The members of this workgroup
are aware that at present the obtained information is not validated and
therefore should be interpreted with utmost caution. Even if the ultra high
field MRI is negative and no focal lesion explaining the epilepsy is found, the
information from the MRI is still valuable to both the treatment and science.
The opposing burden of participation in the study is low, and consists only of
an extra MRI scan, without any associated risks with the used MRI protocols.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Age >=12 years
Drug-resistant focal epilepsy
Work-up for epilepsy surgery
Clear suspicion on the focal onset of the epilepsy
Absent explanatory abnormalities on conventional 3T MRI
Informed consent signed
Exclusion criteria
Incapacitated to sign informed consent
Not mentally competent individuals
Patients and/or legal representative is mentally retarded (IQ < 70)
Pregnant
MRI-exclusion criteria:
Claustrophobia
Pacemaker, neurostimulator, insulin pump or other pump
Aneurysm clips in cerebro
Metal particles in the head (incl. eye)
Hearing prostheses (not all types)
Tattoos above diaphragm
Relative contra-indications (depending on place and kind):
Artificial heart valves
Joint protheses
Overweight (surgery with standard operating table up to 175kg, or
obesity making MRI-scanning impossible due to size)
Other body implants that are not proven safe at 7 or 9.4 Tesla MRI
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66929.068.18 |