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Stereotactic radiotherapy of the epileptogenic focus in patients with pharmacoresistant and inoperable epilepsy: a single-arm interventional prospective clinical trial

Stereotactic radiotherapy of the epileptogenic focus in patients with pharmacoresistant and inoperable epilepsy: a single-arm interventional prospective clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035095
Enrollment
5
Registered
2024-09-17
Start date
2025-01-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

G40

Interventions

Group 1: Stereotactic fractionated radiation with photons (linac-based) of the epileptogenic zone (defined by MRI imaging, together with epileptologist and neurosurgeon), over 2 weeks

Sponsors

Klinik für Strahlentherapie und Radioonkologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Epilepsy diagnosis (of the structural non-neoplastic type) made by an epileptologist and considered pharmacoresistant and inoperable (e.g. due to localization in an eloquent zone or an unacceptable perioperative risk due to underlying or concomitant diseases) or surgery is refused by the patient; - Imaging evidence by means of cMRI of an anatomical region that correlates with the epilepsy diagnosis and can be clearly defined (this is done by means of an interdisciplinary conference where radiotherapists, neuroradiologists, neurosurgeons and epileptologists are present); - multidisciplinary review of the indication for radiotherapy by radiotherapy and epileptology, with the patient being classified as a suitable candidate for stereotactic radiosurgery; - written informed consent.

Exclusion criteria

Exclusion criteria: - pregnancy; - history of radiotherapy in the central nervous system; - patients with cancer predisposition syndromes (e.g. Li-Fraumeni) where each radiation treatment must be indicated with extreme caution.

Design outcomes

Primary

MeasureTime frame
Improvement in seizure frequency (measured using the radiotherapy-adapted Engel classification or RAEC from I or seizure free to IV no significant changes) 6 months after completion of radiotherapy

Secondary

MeasureTime frame
- Side effects of radiotherapy (in particular radionecrosis) - Longitudinal changes in quality of life

Countries

Germany

Contacts

Public ContactDavide Scafa

Klinik für Strahlentherapie

davide.scafa@ukbonn.de+49 228 287 57000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026