Clinical Trials Logo
  1. Home
  2. Amyotrophic Lateral Sclerosis
  3. NCT06219759

Reinnervation and Neuromuscular Transmission in ALS — RANTAL  

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:
Reinnervation and Neuromuscular Transmission in Patients With Amyotrophic Lateral Sclerosis

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06219759
Study type Observational
Source University of Aarhus
Contact Jesper Storgaard, MD
Phone 004520231903
Email jesstg@rm.dk
Status Recruiting
Phase
Start date May 2024
Completion date December 2026
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04428775 - A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease Phase 2
Recruiting NCT04998305 - TJ-68 Clinical Trial in Patients With Amyotrophic Lateral Sclerosis (ALS) and Muscle Cramps Phase 1/Phase 2
Recruiting NCT05951556 - Telehealth Implementation of Brain-Computer Interface N/A
Terminated NCT04579666 - MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT04082832 - CuATSM Compared With Placebo for Treatment of ALS/MND Phase 2/Phase 3
Completed NCT01925196 - Natural History and Biomarkers of Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Caused by the C9ORF72 Gene Mutation
Completed NCT02496767 - Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year Phase 3
Recruiting NCT04816227 - Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
Active, not recruiting NCT04494256 - A Study to Assess the Safety, Tolerability, and Effect on Disease Progression of BIIB105 in Participants With Amyotrophic Lateral Sclerosis (ALS) and Participants With the ALS Ataxin-2 (ATXN2) Genetic Mutation Phase 1/Phase 2
Completed NCT03706391 - Study of ALS Reversals 4: LifeTime Exposures
Recruiting NCT04882904 - Continuous Measurement of Activity in Patients With Muscle Pathology and in Control Subjects. ActiSLA Part. N/A
Completed NCT04557410 - Open Label Study: Treatment of ALS Fatigue With PolyMVA Phase 1
Active, not recruiting NCT04948645 - A Phase 1 Study to Investigate the Safety and Pharmacokinetics of ABBV-CLS-7262 in Patients With Amyotrophic Lateral Sclerosis Phase 1
Not yet recruiting NCT04089696 - Validation of the "ExSpiron©" in Patients With ALS N/A
Not yet recruiting NCT06450691 - Modeling Amyotrophic Lateral Sclerosis With Fibroblasts N/A
Not yet recruiting NCT04220190 - RAPA-501 Therapy for ALS Phase 2/Phase 3
Not yet recruiting NCT05860244 - Effect of Salbutamol on Walking Capacity in Ambulatory ALS Patients Phase 2
Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A