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Ultra-high field MRI in DBS for epilepsy

Ultra-high field MRI in DBS for epilepsy - uhfMRI bij EPI-DBS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48769
Enrollment
15
Registered
2019-04-01
Start date
2019-06-15
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Epilepsy Seizures

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All subjects must be mentally competent (wilsbekwaam) and able to understand the patient information form and decide for participation. All subjects must be aged over 18 years old. All subjects must meet all inclusion requirements of the standard Scannexus screening form All subject must be included for DBS surgery at the MUMC+ for treatment of drug-resistant epilepsy

Exclusion criteria

Exclusion criteria: Neurological diseases other than epilepsy, such as brain tumours, stroke, severe neurotrauma*s, and neurodegenerative diseases. Foreign ferromagnetic objects in the subject*s body or other contra indications for MRI. Prior to scanning, subjects will fill out a screening form. This form will be sent with the information letter to all subjects (Appendices 4 and 5). The screening form will be filled out again on the day of the scan, to ensure any contra indications are known to both the subject and the scanning technician.

Design outcomes

Primary

MeasureTime frame
The main radiological endpoint will be the location of the DBS electrode within the thalamic subnuclei and its structural and functional connectivity. De study parameters used are the DBS electrode contact coordinates (in y, x and z directions) and Euclidean distance of the implanted DBS electrode to the thalamic subnuclei defined by segmentation and by structural and functional MRI. The main clinical endpoint will be the reduction in seizure frequency after DBS.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)