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Whole Neuraxis Low Dose Radiotherapy (LDRT) in patients with Amiotrophic Lateral Sclerosis (ALS)

Whole Neuraxis Low Dose Radiotherapy (LDRT) in patients with Amiotrophic Lateral Sclerosis (ALS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035641
Enrollment
5
Registered
2024-12-03
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

G12.2

Interventions

Group 1: 1st week Department of Neurology • Information about pilot trial • Handing out Patient information • Referral to Department of Radiotherapy Department of Radiotherapy • Verification of suita

Sponsors

Universitätsklinik für Strahlentherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
early detection of side effects according to Common Toxicity Criteria (CTC)

Secondary

MeasureTime frame
Investigations for late effects of radiation according to CTC

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026