Actively Recruiting
Reinnervation and Neuromuscular Transmission in ALS
Led by University of Aarhus · Updated on 2024-08-07
120
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this study is to describe the changes in the neuromuscular connection in patients with amyotrophic lateral sclerosis (ALS). The study consist of three substudies that have the following main hypothesis: 1. that ALS patients do not demonstrate equal capacity for muscle reinnervation and that reinnervation preserves muscle function and thereby slows down progression. 2. that blood concentrations of c-terminal agrin fragment (bCAF) reflect neuromuscular transmission deficiency and that blood concentration of neural cell adhesion molecule reflects degree of muscle denervation in patients. 3. that ALS patients with decrement when examined with repetitive nerve stimulation have more physical fatigue, slower progression, higher degree of reinnervation and higher bCAF compared to ALS patients without decrement. There will be 3 inclusion groups. 1. patients referred for neurophysiological examination on suspicion of motor neuron disease. 2. healthy controls 3. disease control: patients with another motor neuron disease with slow progression. All participants will be invited for at least 1 visit (baseline). If participants in group 1 eventually receive the diagnosis of ALS they will be invited for 2 additional visits 4 og 8 months after baseline visit, respectively. Examinations will consist of: * nerve conduction study * repetitive nerve stimulation (except for healthy controls) to examine impairment of the neuromuscular connection. * motor unit number estimation with MScanFit to estimate number and size of motor units. * ultrasound examination of muscles to measure size and condition of muscles. * questionnaires on fatigue and functional status. * blood sample for measurement of specialized analysis (c-terminal agrin fragment and neural cell adhesion molecule) and routine analysis (liver and kidney function as well as neurofilament light chain) * muscle strength assessment manually and by dynamometer to follow progression of muscle weakness * bioelectrical impedance measurement to follow the overall body composition.
CONDITIONS
Official Title
Reinnervation and Neuromuscular Transmission in ALS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Referred to neurophysiological exam for suspected motor neuron disease or diagnosed with ALS within the last 3 months
- Age 18 years or older
- Able and willing to provide informed consent
- Diagnosed with a slow progressive motor neuron disease (for disease control group)
- Age 18 years or older (for disease control group)
- Able and willing to provide informed consent (for disease control group)
You will not qualify if you...
- Previous central or peripheral nervous system disease
- Diabetes
- Signs of polyneuropathy at baseline nerve test
- Pacemaker
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurology, Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200
Actively Recruiting
Research Team
J
Jesper Storgaard, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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