Understanding neuromuscular connections in ALS patients
Reinnervation and Neuromuscular Transmission in Patients With Amyotrophic Lateral Sclerosis
This study looks at how the connections between nerves and muscles change in people with ALS to see if there are differences compared to healthy individuals and those with other diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus, Central Jutland) |
| Trial ID | NCT06219759 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe changes in neuromuscular connections in patients with amyotrophic lateral sclerosis (ALS). It consists of three substudies focusing on muscle reinnervation capacity, blood biomarkers related to neuromuscular transmission, and the relationship between nerve stimulation responses and physical fatigue. The study will include ALS patients, healthy controls, and disease controls to compare findings across different groups. Participants will undergo neurophysiological examinations to gather data on their condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are suspected of having motor neuron disease or have been diagnosed with ALS within the last three months.
Not a fit: Patients with prior central or peripheral nervous system diseases, diabetes, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of ALS, potentially slowing disease progression.
How similar studies have performed: While similar studies have explored aspects of neuromuscular transmission in ALS, this specific approach focusing on reinnervation and biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aarhus, Central Jutland
- Department of Neurology, Aarhus University Hospital — Aarhus, Central Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Jesper H Storgaard, MD — Aarhus University and Department of Neurology, Aarhus University Hospital
- Study coordinator: Jesper Storgaard, MD
- Email: jesstg@rm.dk
- Phone: 004520231903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.