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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00026742

Enrollment

Registered

2021-10-06

Start date

2021-09-24

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G40.2

Interventions

Group 1: Single arm study - all patients have 3T-MRI negative epilepsy and will undergo a 7T MRI exam to detect putative epileptogenic lesions, which remained undiscovered after the 3T MRI.

Eligibility

Sex/Gender

All

Age

18 Years to 105 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. the proportion of patients in whom apparent structural brain lesions are detected on ultra high field MRI. 2. Postoperative seizure outcome one year after resective epilepsy surgery (Engel/ILAE class).	—

Secondary

Measure	Time frame
1. Differences between suspected ROIs in 3Tesla MRI and their correlates in 7/9.4Tesla MRI 2. Correlation between suspected ROI in the non- or semi-invasive workup and the ultra high field MRI data 3. Histopathological diagnosis of surgical specimen	—

Countries

Germany, Netherlands

Contacts

Public ContactDaniel Delev

Universitätsklinikum Aachen Klinik für Neurochirurgie

ddelev@ukaachen.de0241 80 88481

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026