Amyotrophic Lateral SclerosisNCT05764434
ALS Spinal Cord Gray and White Matter Study
An observational study of Amyotrophic Lateral Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2018to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients diagnosed with possible, probable, and definite Amyotrophic Lateral Sclerosis acc. to the El Escorial aged 18 years or older can participate in this study. Healthy control persons are chosen to individually match the included patients. Additionally, patients with other motor neuron diseases (not ALS) will be included.
Who may be able to join
- 18 years or older
- neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria
- at baseline: able to lie in an MRI scanner for one hour
- 18 years or older
- able to lie in MRI scanner for one hour
Who cannot join
- active other neurological or neuromuscular condition explaining the symptoms or a significant part of it
- other neurological or neuromuscular conditions interfering with the examinations
- severe cervical spinal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
- other severe chronic disease
- pregnancy
- general contraindications against MRI scanning (e.g. metal implants, pacemakers)
Show all 25Show fewer
- not able to read the patient information due to language barriers (patient information in English and French may be provided)
- major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel
- neurological or neuromuscular conditions
- other severe chronic disease
- pregnancy
- general contraindications against MRI scanning (e.g. metal implants, pacemakers)
- relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
- not able to read the patient information due to language barriers (patient information in English and French may be provided)
- Inclusion criteria (patients with Motor Neuron Diseases other than ALS):
- 18 years or older
- neurologist-confirmed Motor Neuron Disease (not ALS)
- able to lie in MRI scanner for one hour
- Exclusion criteria (patients with Motor Neuron Diseases other than ALS):
- other severe neurologic disease
- other severe chronic disease
- pregnancy
- general contraindications against MRI scanning (e.g. metal implants, pacemakers)
- relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
- not able to read the patient information due to language barriers (patient information in English and French may be provided)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Regina Schlaeger, PD Dr., 0041 61 328 67 49, regina.schlaeger@usb.ch
Janina Wendebourg, Dr., 0041 556 57 99, janina.wendebourg@usb.ch
About this study
Official title: Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis
This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed.
Examinations for patients and healthy control persons are scheduled every six months over a time span of two years.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Amyotrophic Lateral Sclerosis, Spinal Cord Magnetic Resonance Imaging
- 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.
Magnetic Resonance ImagingDiagnostic test
Magnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA)
| Study group | Role | What they receive |
|---|---|---|
| Patients with Amyotrophic Lateral Sclerosis | Patients with a possible, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis according to the El Escorial Criteria. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| Healthy Control Persons | Healthy control persons matching the ALS patient group in sex and age Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| Patients with other Motor Neuron Diseases | Patients with Motor Neuron Diseases other than ALS Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Gray Matter Baseline
Spinal cord gray matter cross-sectional area in mm2
Measured: baseline
Spinal Cord Gray Matter 6 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Measured: 6 month follow-up
Spinal Cord Gray Matter 12 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Measured: 12 month follow-up
Spinal Cord Gray Matter 18 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Measured: 18 month follow-up
Spinal Cord Gray Matter 24 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Measured: 24 month follow-up
Secondary outcomes (7)
Spinal Cord White Matter
Spinal cord white matter cross-sectional area in mm2
Measured: baseline, months 6, 12, 18 and 24
Spinal Cord Total Area
Total spinal cord cross-sectional area in mm2
Measured: baseline, months 6, 12, 18 and 24
ALS Functional Rating Scale
ALS Functional Rating Scale (ALSFRS-R)
Measured: baseline, months 6, 12, 18 and 24
Neurofilament Light Chain Levels
Neurofilament Light Chain Levels (pg/ml)
Measured: baseline, months 6, 12, 18 and 24
Sniff nasal inspiratory pressure
Sniff nasal inspiratory pressure (SNIP) (cmH2O)
Measured: baseline, months 6, 12, 18 and 24
Segmental Muscle Force
Segmental Muscle Force assessed by hand-held dynamometry (N)
Measured: baseline, months 6, 12, 18 and 24
MUNIX
Motor Unit Number Index (MUNIX) in selected muscles
Measured: baseline, months 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 May 2018
- Primary completion1 May 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Regina Schlaeger, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764434
- Sponsor's protocol ID
- ALS_SC_MRI
- Status last verified
- Nov 2023
- First submitted
- 27 Feb 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wendebourg MJ, Kesenheimer E, Sander L, Weigel M, Weidensteiner C, Haas T, Madoerin P, Diebold M, Deigendesch N, Neuhaus D, Naumann N, Neuwirth C, Braun N, Weber M, Granziera C, Scheurer E, Lenz C, Schweikert K, Sinnreich M, Lieb J, Bieri O, Schlaeger R. The Lateral Corticospinal Tract Sign: An MRI Marker for Amyotrophic Lateral Sclerosis. Radiology. 2024 Sep;312(3):e231630. doi: 10.1148/radiol.231630.
PubMed 39287519
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05764434
- Acronym / sponsor ID
- ALS_SC_MRI
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Spinal Cord Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 10 Mar 2023 (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.
This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed.
Examinations for patients and healthy control persons are scheduled every six months over a time span of two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Amyotrophic Lateral Sclerosis | – | Diagnostic Test: Magnetic Resonance ImagingPatients with a possible, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis according to the El Escorial Criteria. |
| Healthy Control Persons | – | Diagnostic Test: Magnetic Resonance ImagingHealthy control persons matching the ALS patient group in sex and age |
| Patients with other Motor Neuron Diseases | – | Diagnostic Test: Magnetic Resonance ImagingPatients with Motor Neuron Diseases other than ALS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with possible, probable, and definite Amyotrophic Lateral Sclerosis acc. to the El Escorial aged 18 years or older can participate in this study. Healthy control persons are chosen to individually match the included patients. Additionally, patients with other motor neuron diseases (not ALS) will be included.
Key inclusion criteria (5 listed)
- 18 years or older
- neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria
- at baseline: able to lie in an MRI scanner for one hour
- 18 years or older
- able to lie in MRI scanner for one hour
Key exclusion criteria (25 listed)
- active other neurological or neuromuscular condition explaining the symptoms or a significant part of it
- other neurological or neuromuscular conditions interfering with the examinations
- severe cervical spinal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
- other severe chronic disease
- 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 |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA) | Diagnostic test | Healthy Control Persons, Patients with Amyotrophic Lateral Sclerosis, Patients with other Motor Neuron Diseases |
Primary outcome
Spinal Cord Gray Matter Baseline
Time frame: baseline
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 6 month follow-up
Time frame: 6 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 12 month follow-up
Time frame: 12 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 18 month follow-up
Time frame: 18 month follow-up
Spinal cord gray matter cross-sectional area in mm2
Spinal Cord Gray Matter 24 month follow-up
Time frame: 24 month follow-up
Spinal cord gray matter cross-sectional area in mm2
7 secondary outcomes
Spinal Cord White Matter
Time frame: baseline, months 6, 12, 18 and 24
Spinal Cord Total Area
Time frame: baseline, months 6, 12, 18 and 24
ALS Functional Rating Scale
Time frame: baseline, months 6, 12, 18 and 24
Neurofilament Light Chain Levels
Time frame: baseline, months 6, 12, 18 and 24
Sniff nasal inspiratory pressure
Time frame: baseline, months 6, 12, 18 and 24
Segmental Muscle Force
Time frame: baseline, months 6, 12, 18 and 24
MUNIX
Time frame: baseline, months 6, 12, 18 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 39287519Wendebourg MJ, Kesenheimer E, Sander L, Weigel M, Weidensteiner C, Haas T, Madoerin P, Diebold M, Deigendesch N, Neuhaus D, Naumann N, Neuwirth C, Braun N, Weber M, Granziera C, Scheurer E, Lenz C, Schweikert K, Sinnreich M, Lieb J, Bieri O, Schlaeger R. The Lateral Corticospinal Tract Sign: An MRI Marker for Amyotrophic Lateral Sclerosis. Radiology. 2024 Sep;312(3):e231630. doi: 10.1148/radiol.231630.
- 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. This study is not recruiting at the moment.
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 Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Regina Schlaeger, PD Dr. (0041 61 328 67 49, regina.schlaeger@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Gray Matter Baseline (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764434, which also lists 1 linked publication.
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 14 Nov 2023.