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

Recruiting
Conditions
G40.2
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Registration Number
DRKS00026742
Lead Sponsor
Akademisches Krankenhaus Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
20
Inclusion Criteria

Patients in the age of > 18 years
Drug-resistant focal epilepsy: the treatment with at least two anti-epileptic drugs did not lead to seizure control.
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

Patients with incapacitated to sign informed consent or if a courtly appointed caretaker or a representative with health care proxy is not willing to give informed consent
Mentally incompetent individuals
Patients and/or legal representative is mentally retarded (IQ <70)
Women who are pregnant at the time of study participation (an urine- pregnancy test will be conducted before examination)
Patients in the age of < 18 years
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
Artificial heart valves
Joint protheses
Overweight (surgery with standard operating table up to 175kg, or obesity making MR1-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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. the proportion of patients in whom apparent structural brain lesions are detected on ultra high field MRI. <br>2. Postoperative seizure outcome one year after resective epilepsy surgery (Engel/ILAE class).
Secondary Outcome Measures
NameTimeMethod
1. Differences between suspected ROIs in 3Tesla MRI and their correlates in 7/9.4Tesla MRI<br>2. Correlation between suspected ROI in the non- or semi-invasive workup and the ultra high field MRI data<br>3. Histopathological diagnosis of surgical specimen
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