NCT06219759 Reinnervation and Neuromuscular Transmission in ALS
| NCT ID | NCT06219759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-05-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Referred to clinical neurophysiological examination on suspicion of motor neuron disease or diagnosed with ALS according to Gold Coast criteria within the last 3 months. * Age ≥18 years old * Able and willing to provide informed consent Exclusion Criteria: * Former central or peripheral nervous system disease * Diabetes * Electrophysiological signs of polyneuropathy at baseline visit * Pacemaker * Pregnancy For disease controls the exclusion criteria are the same, but the inclusion criteria: * Diagnosed with disease with slow, progressive loss of motor neurons * Age ≥18 years old * Able and willing to provide informed consent
Contact & Investigator
Jesper H Storgaard, MD
PRINCIPAL INVESTIGATOR
Aarhus University and Department of Neurology, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT06219759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06219759 currently recruiting?
Yes, NCT06219759 is actively recruiting participants. Contact the research team at jesstg@rm.dk for enrollment information.
Where is the NCT06219759 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT06219759 clinical trial?
NCT06219759 is sponsored by University of Aarhus. The principal investigator is Jesper H Storgaard, MD at Aarhus University and Department of Neurology, Aarhus University Hospital. The trial plans to enroll 120 participants.
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