Registry trial of the MND-NET

Project title:
Deutsches Netzwerk für Motoneuronerkrankungen – German Network for Motor Neuron Diseases (MND-NET):
A Registry and Trace Study

Study lead:
Prof. Dr. med. Albert Ludolph (phone +49 731-177-1200), Klinik und Poliklinik für Neurologie,
Universitätsklinikum Ulm, Oberer Eselsberg 45, 89081 Ulm

Objectives of the registry trial

To establish a high quality patient registry linked to biomaterials with the goal of efficient patient recruitment for meaningful drug-therapeutic trials.
The implementation of new disease-modifying and symptomatic therapy approaches.
The establishment of biomarkers. Biomarkers enable more accurate and earlier diagnosis, and they provide information on disease activity and progression. The goal is to establish biomarkers in terms of clinical laboratory parameters and other molecular markers as well as imaging and metabolic parameters.
Improved medical and psychosocial care of patients with motor neuron disease.
The documentation of disease progression and clinically accurate phenotyping of the disease.

The patient registry of the MND-NET is an electronic patient database that maps the disease course of patients with motor neuron diseases.
Data storage is exclusively in pseudonymized form.
Demographics, clinical characteristics, comorbidities, medication, nutritional state, respiratory state and the ALSFRS-R, among others, are included in the description of the disease course.

Under Centers, you will find the network’s centers, where experienced physicians will provide you with comprehensive information about participating in the patient registry.

Description of the MND/ALS-registry trial

In the clinic of the respective study center, routine clinical scales are collected during the examination to assess the severity of the disease and to document the symptoms, e.g. the ALS Functional Rating Score Revised – ALS-FRSR. These clinical scales are based on information obtained in the clinical neurological examination.
Due to the frequent association of MNE with frontotemporal lobar degeneration (FTLD), cognitive performance testing is performed in addition to motor skill assessments.

These data are collected by the respective study center from the treating physician or neuropsychologist upon inclusion in the study. The patients usually have a close relationship to the respective centers, so that regular follow-up examinations take place during which the follow-up data are collected.

In addition to the usual personal data such as age, gender and duration of illness, the body mass index (BMI) and other values determined in the course of routine diagnostics are recorded and stored pseudonymously.

Furthermore, the usual technical routine examinations required for the diagnostics of a motor neuron disease, such as electromyographic examinations, head MRI or electrophysiological examinations, are recorded in a standardized manner.

For biomaterial collection, the patient can consent separately for blood or cerebrospinal fluid sampling.

Genetic analysis of blood samples is possible and requires explicit patient consent.

In the course of further differential diagnostic clarification, tissue biopsies of muscles and skin may be necessary to exclude important differential diagnoses such as inflammatory muscle and nerve diseases. The patient may consent to the availability of muscle and skin tissue for scientific purposes.

For more information on how to participate in the MND-NET registry study, please contact the MND-NET centers.