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ALS-Electrode: Novel Neuro-electrical Biomarkers of Heterogeneous Network Degeneration in Amyotrophic Lateral Sclerosis for Quantifying the Progression and Outcome in Clinical Trials

ALS-Electrode: Novel Neuro-electrical Biomarkers of Heterogeneous Network Degeneration in Amyotrophic Lateral Sclerosis for Quantifying the Progression and Outcome in Clinical Trials - ALS-Electrode

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52587
Enrollment
650
Registered
2019-07-03
Start date
2020-01-14
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Motor neuron disease, Amyotrophic lateral sclerosis

Interventions

EEG/EMG

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Belong to one cohort of interest a. ALS patients: definite, probable, probable-laboratory supported or possible ALS according to the revised El Escorial criteria (Brooks et al., 2000) b. PMA/PLS patients: patients with clinical diagnosis of PMA or PLS, after excluding other diseases. c. Asymptomatic carriers: Carriers of ALS-related gene mutations with no neurological symptoms associated with ALS d. Healthy controls: age- and gender-matched to patient groups, intact physical ability to take part in the experiment 2. Age 18-80 years (inclusive) 3. Capable of thoroughly understanding the study information given; has signed the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for all participants: • Pregnancy • History of major head trauma  • Any medical condition associated with neuropathy (e.g. diabetes), transient  ischemic attack, stroke, epilepsy, seizure disorder, brain tumours and other  comorbidities (e.g. human immunodeficiency virus) • Alcohol dependence syndrome, current use of neuroleptic medications or high  dose psychoactive medication • History of reaction or allergy to recording environments, equipment and the  recording gels • Tracheostomy, tracheostomal ventilation of any type or frequent need for  (non)-invasive ventilation Further exclusion criteria for healthy controls and ALS family members:  History of neuromuscular, neurological or active psychiatric disease.

Design outcomes

Primary

MeasureTime frame
Primary Final Endpoints: Discovered ALS biomarker(s) for reliable and early detection, as well as distinction between different ALS subphenotypes and healthy people based on differences in ERPs identified using EEG/EMG experiments with subsequent source localisation.

Secondary

MeasureTime frame
Secondary study outcomes: • EEG and EMG (anonymised) data sets, for wider research purposes • Assessing the difference in terms of cortical network dysfunction in the cognitive domains between different ALS sub-phenotypes and healthy controls • Cross validation between obtained task-based (ERP) and resting-state alternations in both motor and cognitive networks. • Research Publications

Countries

Netherlands

Contacts

Public ContactS Dukic

Universitair Medisch Centrum Utrecht

als-onderzoek@umcutrecht.nl088-7555887

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)