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Detecting drug effects in ALS patients using electrophysiological biomarkers

Detecting drug effects in ALS patients using electrophysiological biomarkers - Electrophysiological biomarkers in ALS patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56704
Enrollment
115
Registered
2023-10-31
Start date
2025-06-16
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

ALS, Amyotrophic Lateral Sclerosis

Interventions

n.v.t.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime frame
Excitability measures of the peripheral nerve. Several distinct measurements will provide in-debt information regarding the functioning of different ion-channels.

Secondary

MeasureTime 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

Public ContactB.T.H.M. Sleutjes

Universitair Medisch Centrum Utrecht

b.sleutjes@umcutrecht.nl+31887557961

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)