Non-invasive radiation treatment for drug-resistant epilepsy
Precision Radiation Treatment for Epilepsy (PRECISION)
This study is testing a non-invasive radiation treatment for adults with drug-resistant epilepsy to see if it works better than standard medications and therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht Radiation Oncology Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05182437 on ClinicalTrials.gov |
What this trial studies
The PRECISION study offers a non-invasive treatment option for adults with drug-resistant localized epilepsy who are not candidates for surgery. Participants will receive a single session of LINAC-based Stereotactic Radiotherapy (SRT) after thorough localization of the epileptogenic zone by a team of specialists. This randomized waitlist-controlled trial compares the effects of SRT against standard treatments, such as antiepileptic drugs and neuromodulation. The goal is to provide a curative treatment alternative while maintaining health costs comparable to existing therapies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with drug-resistant localized epilepsy who have not responded to multiple antiepileptic medications.
Not a fit: Patients with generalized epilepsy or those who are not eligible for SRT due to other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a curative option for patients with epilepsy who currently have limited treatment choices.
How similar studies have performed: Previous studies have shown promising results for SRT in treating drug-resistant epilepsy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations 3. 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 4. The patient or caretaker is able to keep an epilepsy diary 5. The patient has a diagnosis of epilepsy established by a dedicated neurologist 6. 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) 7. Video electroencephalography and work-up in the epilepsy surgery working group to determine a well-circumscribed seizure focus is available 8. Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to be targeted with SRT, correlating with the EZ hypothesis; 9. 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). 10. The patient has completed a standard battery of neuropsychological testing 11. 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 12. 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. Exclusion Criteria: 1. Pregnancy 2. If a radiation treatment plan without exceeding the constraints for the organs at risk is not feasible. 3. Prior cranial radiotherapy 4. If radiotherapy treatment is not possible for diverse reasons. 5. If the subject has clinically significant and uncontrolled major other medical condition(s) including but not limited to: ii. 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.
Where this trial is running
Maastricht, Limburg
- Maastricht Radiation Oncology — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Daniëlle Eekers, Dr. — Radiation Oncologist
- Study coordinator: Daniëlle Eekers, Dr.
- Email: danielle.eekers@maastro.nl
- Phone: +3188 44 55 600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.