Value of Ultra High field MRI for lesion detection in patients with suspected focal epilepsy and negative 3T MRI

Recruiting

Conditions: Drug-resistent focal epilepsy
epilepsy
10039911
10009720

Registration Number: NL-OMON54565

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: the proportion of patients in whom apparent structural brain<br /><br>lesions are detected on ultra high field MRI. Postoperative seizure outcome one<br /><br>year after resective epilepsy surgery (Engel/ILAE class).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>1. Differences between the ROI as previous determined in the non- or<br /><br>semi-invasive workup, and the contralateral (non-epileptic) side.<br /><br>2. Association between suspected ROI in the non- or semi-invasive workup and<br /><br>the ultra high field MRI data.<br /><br>3. Histopathological diagnosis of surgical specimen<br /><br>4. Differences in ultra high field MRI performed in the same patient</p><br>