ALS, Amyotrophic Lateral Sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in the study, a subject must meet the following criteria: o Age >=18 years o Written informed consent For the first part (as part of the diagnostic process and treatment-naïve subjects): o Patients with suspected MND o No use of Riluzole medication o Participation in the NMZ biobank (neuromuscular biobank from the UMC Utrecht) For the second part (five serial electrophysiological follow-up recordings): o Diagnosis of ALS, by either Gold Coast Criteria or El Escorial o Routine use of Riluzole twice daily o A measurable maximum CMAP >2mV in the abductor pollicis brevis (APB) For the disease control group (single electrophysiological follow-up recording) o Participation in first part (pre-diagnostic assessment)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study (please refer to C1 document, 4.3): - Exclusion of study participation according to the TRICALS profile risk calculator, a validated tool that screens patients for eligibility for ALS study participation for the five follow-up recordings - Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excitability measures of the peripheral nerve. Several distinct measurements will provide in-debt information regarding the functioning of different ion-channels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Excitability measures of the peripheral nerve. Several distinct measurements will provide in-debt information regarding the functioning of different ion-channels. CMAP (compound muscle action potential)-scan, to determine number of functional motor units, their size and stability. Riluzole and neurofilament assessment (in blood). Clinical tests (eg. lung capacity, strength assessments, neurological clinical assessment, ALS questionnaire | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Utrecht