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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54565

Enrollment

Registered

2019-05-08

Start date

2021-05-07

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-resistent focal epilepsy

Interventions

None listed

Eligibility

Age

12 Years to 99 Years

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 Patients and/or legal representative is mentally retarded (IQ

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results