Precision Radiation Treatment for Epilepsy (PRECISION)

Korábbi kezelés

• If a radiation treatment plan without exceeding the constraints for the organs at risk is not feasible.
• Prior cranial radiotherapy
• If radiotherapy treatment is not possible for diverse reasons.

Más betegség

• If the subject has clinically significant and uncontrolled major other medical condition(s) including but not limited to:
• psychiatric illness/social situation that would limit compliance with study requirements iii. any medical condition, with the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities iv. Progressive co-morbidity which limits overall survival.

Egyéb

• Pregnancy

• Age ≥ 18 years
• Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations
• Willingness to use contraception by a method that is deemed effective by the Investigator during the SRT treatment and for at least 30 days following the SRT therapy
• The patient or caretaker is able to keep an epilepsy diary
• The patient has a diagnosis of epilepsy established by a dedicated neurologist
• The patient had at least 3 focal-onset seizures over a 3-month period despite two or more antiepileptic medication trials (according ILAE Task Force on therapeutic strategies)
• Video electroencephalography and work-up in the epilepsy surgery working group to determine a well-circumscribed seizure focus is available
• Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to be targeted with SRT, correlating with the EZ hypothesis;
• A functional MRI to lateralize language or localize visual, motor and/or sensory eloquent cortex has been performed in selected patients (if the lesion is expected to be located, based on anatomy, in the language areas).
• The patient has completed a standard battery of neuropsychological testing
• The patient been deemed an appropriate candidate for stereotactic radiosurgery by a dedicated Radiation Oncologist and Neurosurgeon/Epileptologist and referred for the study by one of the Dutch regional multidisciplinary epilepsy surgery working groups
• Patients that were rejected for surgery in an earlier stage can participate in the trial if the last change of the NVS/DBS settings were more than 1 year ago or NVS/DBS was not (yet) tried.