Amyotrophic Lateral SclerosisRANTALNCT06219759
Reinnervation and Neuromuscular Transmission in ALS
An observational study of Amyotrophic Lateral Sclerosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Observational study
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients refered for neurophysiological examination or patients followed at out-patient clinics.
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- Diagnosed with disease with slow, progressive loss of motor neurons
- Age ≥18 years old
- Able and willing to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Neurology, Aarhus University Hospital
Aarhus, Central Jutland, 8200
Jesper H Storgaard, MD, 004520231903, jesstg@rm.dk
About this study
Official title: Reinnervation and Neuromuscular Transmission in Patients With Amyotrophic Lateral Sclerosis
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:
- that ALS patients do not demonstrate equal capacity for muscle reinnervation and that reinnervation preserves muscle function and thereby slows down progression.
- 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.
- 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.
Read more
There will be 3 inclusion groups.
- patients referred for neurophysiological examination on suspicion of motor neuron disease.
- healthy controls
- 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
- Amyotrophic Lateral Sclerosis
- Being tested
- Observational study
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Observational study.
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Patients enrolled prior to determination of diagnosis on referral to neurophysiological examination. When the diagnosis is later established they get categorized as ALS patients.
ALS patients with recent diagnosis might also be included directly. Receives: Other: Observational study | |
| ALS mimic disease patients | Patients enrolled prior to determination of diagnosis on referral to neurophysiological examination. When diagnosis is later established and the diagnosis is NOT ALS they get categorized as ALS mimic disease patients. Receives: Other: Observational study | |
| Healthy controls | Healthy controls. Receives: Other: Observational study | |
| Disease controls | Patients with another motor neuron disease than ALS with slow progression. Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinnervation
Difference between fast and slow progressing patients in change in mean amplitude size of motor units as estimated by MScanFit motor unit number estimation.
Measured: From baseline and 8 months
Blood biomarkers
Difference in blood concentration of c-terminal agrin fragment and neural cell adhesion molecule at baseline between ALS patients, healthy controls and ALS mimic disease patients.
Measured: Baseline
Fatigue and decrement
Difference in proportion of participants with decrement between ALS patients and ALS mimic disease patients as well as degree of fatigue among ALS patients with and without neuromuscular transmission deficiency.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start17 May 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jesper H Storgaard, MD, Principal investigator, Aarhus University and Department of Neurology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219759
- Sponsor's protocol ID
- 8340
- Other IDs
- 1-10-72-153-23
- Acronym
- RANTAL
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinnervation and Neuromuscular Transmission in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06219759
- Acronym / sponsor ID
- RANTAL / 8340
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 17 May 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- that ALS patients do not demonstrate equal capacity for muscle reinnervation and that reinnervation preserves muscle function and thereby slows down progression.
- 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.
- 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.
- patients referred for neurophysiological examination on suspicion of motor neuron disease.
- healthy controls
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | Other: Observational studyPatients enrolled prior to determination of diagnosis on referral to neurophysiological examination. When the diagnosis is later established they get categorized as ALS patients. ALS patients with recent diagnosis might also be included directly. |
| ALS mimic disease patients | – | Other: Observational studyPatients enrolled prior to determination of diagnosis on referral to neurophysiological examination. When diagnosis is later established and the diagnosis is NOT ALS they get categorized as ALS mimic disease patients. |
| Healthy controls | – | Other: Observational studyHealthy controls. |
| Disease controls | – | Other: Observational studyPatients with another motor neuron disease than ALS with slow progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients refered for neurophysiological examination or patients followed at out-patient clinics.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Former central or peripheral nervous system disease
- Diabetes
- Electrophysiological signs of polyneuropathy at baseline visit
- Pacemaker
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyObservational study. | Other | ALS mimic disease patients, ALS patients, Disease controls, Healthy controls |
Primary outcome
Reinnervation
Time frame: From baseline and 8 months
Difference between fast and slow progressing patients in change in mean amplitude size of motor units as estimated by MScanFit motor unit number estimation.
Blood biomarkers
Time frame: Baseline
Difference in blood concentration of c-terminal agrin fragment and neural cell adhesion molecule at baseline between ALS patients, healthy controls and ALS mimic disease patients.
Fatigue and decrement
Time frame: Baseline
Difference in proportion of participants with decrement between ALS patients and ALS mimic disease patients as well as degree of fatigue among ALS patients with and without neuromuscular transmission deficiency.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesper H Storgaard, MD principal investigator
Aarhus University and Department of Neurology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesper Storgaard, MD (004520231903, jesstg@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinnervation (time frame: From baseline and 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.