G12.2
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Male and female patients =18 years of age with first diagnosis of Spinal or Bulbar-Onset of ALS - Ability to understand the pilot trial and give an informed consent - Ability to undergo proposed assessment alone or accompanied by a caregiver - Ability to follow the 5-days RT regiment, alone or accompanied by a caregiver
Exclusion criteria
Exclusion criteria: • Inclusion in another interventional clinical study • Previous brain radiotherapy • Oncologic disease (excluding skin cancer) active or in remission from less than 5 years • Alcohol and/or other drugs dependence during the previous 12 months (DSM-V or ICD-10 criteria) • Significant psychiatric disease or cognitive deficits • Active or recent (within 3 months) cerebral infection or haemorrhage • Immunocompromised status • Female who is pregnant or nursing or who plans to get pregnant during the course of Low Dose Radiotherapy (LDRT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| early detection of side effects according to Common Toxicity Criteria (CTC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigations for late effects of radiation according to CTC | — |
Countries
Germany