Registry Study of Assistive Devices, Medicines and Healthcare Measures in ALS, SMA and Other Neurological Diseases.

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT05852418
• Lead Sponsor: Ambulanzpartner Soziotechnologie APST GmbH

Brief Summary

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with Amyotrophic lateral sclerosis (ALS), Spinal muscular atrophy (SMA) and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes.

Detailed Description

This registry study aims to collect data on the provision of assistive devices, medicines, and other healthcare measures, such as ventilation therapy and nutrition support, in patients with ALS, SMA and other neurological disorders. The data collected should describe the clinical practice, meaning real-world evidence and patient-reported outcomes. The collected data include clinical characteristics, medical history, assessment scales, such as ALS functional rating scale-revised (ALSFRS-R), prognosis indicators, such as ALS progression rate, biomarker data, such as serum Neurofilament light chain (sNfL), genetic data, such as the mutation status of SOD1, FUS, c9orf72, TARDBP in ALS, SMN1 in SMA patients, innovative drugs such as Tofersen, Nusinersen, Risdiplam, as well as symptomatic drugs, patient-reported outcome data being captured using questionnaires and established clinical scales on medication expectation and treatment satisfaction.

Study Timeline

• Study Start: 2015-10-30
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2028-12-31
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

Diagnosis of a chronic neurological disease -

Exclusion Criteria

Lack of cooperation and unwillingness to store and share medical data collected in the registry study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires	10 years	The systematic recording of neurological treatment and its evaluation by patients via specific questionnaires

Trial Locations

Locations (16)

Christoph Münch; 🇩🇪 Berlin, Germany

Klinik für Neurodegenrative Erkrankungen und Gerontopsychiatrie, ALS-Ambulanz und Huntington Ambulanz, Universitätsklinikum; 🇩🇪 Bonn, Germany

Neurologische Klinik, ALS-Ambulanz, Alfried Krupp Krankenhaus Rüttenscheid, Essen; 🇩🇪 Essen, Germany

Ambulanz für Neuromuskuläre und Motoneuron-Erkrankungen, Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Universitätklinikum; 🇩🇪 Mannheim, Germany

Klinik für Neurologie, Universitätsmedizin, Georg-August-Universität Göttingen; 🇩🇪 Göttingen, Germany

Neurologie und Poliklinik, Universitätsklinikum; 🇩🇪 Heidelberg, Germany

Klinik und Poliklinik für Neurologie; 🇩🇪 Leipzig, Germany

Neurologisches Klinik, Ambulanz für Motoneuronerkrankungen und ALS, Diakonissenkrankenhaus; 🇩🇪 Mannheim, Germany

Klinik und Poliklinik für Neurologie, Medizinische Fakultät Carl Gustav Carus, Technischen Universität Dresden; 🇩🇪 Dresden, Germany

Neurologische Klinik und Poliklinik, Universitätsklinikum Bergmannsheil; 🇩🇪 Bochum, Germany

ALS- und Muskelambulanz, Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Klinik für Neuroogie-Präzisionsneurologie, Universitätsklinikum Schleswig-Holstein, Universität zu Lübeck; 🇩🇪 Lübeck, Germany

Klinik für Schlafmedizin und Neuromuskuläre Erkrankungen, Westfälische Willhelms-Universität Münster; 🇩🇪 Münster, Germany

Klinik für Innere Medizin, Neurologie, UKM Marienhospital Steinfurt; 🇩🇪 Steinfurt, Germany

Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany