Epilepsy Focal drug-resistant epilepsy
Conditions
Interventions
All patients will undergo an ultra high field MRI-scan of the brain (in 10 patients twice, i.e. both 7T+9.4T).
Sponsors
Academic hospital Maastricht (azM), Maastricht, The Netherlands
Eligibility
Inclusion criteria
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
Exclusion criteria: Incapacitated to sign informed consent Not mentally competent individuals (age 16 and above). 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of apparent structural abnormalities on Ultra high field MR brain imaging in patients with focal drug-resistant epilepsy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ultra high field MRI differences between the suspected regions of interest (ROI) (blurring cortical-subcortical junction/cortical thickening/transmantle sign/hyperintensity of grey and white matter/abnormal gyral-sulcal pattern/segmental or lobar hypoplasia) as previous determined and the contralateral side in patients with a negative 3 Tesla MRI. 2. Association between ROI (blurring cortical-subcortical junction/cortical thickening/transmantle sign/hyperintensity of grey and white matter/abnormal gyral-sulcal pattern/segmental or lobar hypoplasia) in the non- or semi-invasive workup modalities and in the ultra high field MRI data. 3. Histopathological diagnosis of surgical specimen. 4. Postoperative seizure outcome (Engel/ILAE class) minimally 1 year postoperative. 5. Intra-observer agreement between 2 ultra high field MRI scans (7T, 9.4T in 10 patients) that are performed in the same patient and assessed by the same observer. In addition, we will assess inter-observer agreement by repeating the assessment of the ultra high field MRI scans by a second observer. | — |
Outcome results
None listed