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Reinnervation and Neuromuscular Transmission in ALS

NCT06219759 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-08-07

No results posted yet for this study

Summary

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

Interventions

OTHER

Observational study

Observational study.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jesper H Storgaard, MD · Aarhus University and Department of Neurology, Aarhus University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219759 on ClinicalTrials.gov