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

Recruiting

Conditions: motor neuron disease
muscle disorder
10029317

Registration Number: NL-OMON52587

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 330

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 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 patients:
• Insufficient dominant hand function to perform button pressing (SART/Stroop)
and/or motor tasks
Further exclusion criteria for healthy controls and asymptomatic carriers:
History of neuromuscular, neurological or active psychiatric disease.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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