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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Amyotrophic Lateral Sclerosis | Patients with a possible, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis according to the El Escorial Criteria. |
| |
| Healthy Control Persons | Healthy control persons matching the ALS patient group in sex and age |
| |
| Patients with other Motor Neuron Diseases | Patients with Motor Neuron Diseases other than ALS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | Magnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Cord Gray Matter Baseline | Spinal cord gray matter cross-sectional area in mm2 | baseline |
| Spinal Cord Gray Matter 6 month follow-up | Spinal cord gray matter cross-sectional area in mm2 | 6 month follow-up |
| Spinal Cord Gray Matter 12 month follow-up | Spinal cord gray matter cross-sectional area in mm2 | 12 month follow-up |
| Spinal Cord Gray Matter 18 month follow-up | Spinal cord gray matter cross-sectional area in mm2 | 18 month follow-up |
| Spinal Cord Gray Matter 24 month follow-up | Spinal cord gray matter cross-sectional area in mm2 | 24 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Spinal Cord White Matter | Spinal cord white matter cross-sectional area in mm2 | baseline, months 6, 12, 18 and 24 |
| Spinal Cord Total Area | Total spinal cord cross-sectional area in mm2 |
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Inclusion Criteria (patients):
Exclusion Criteria (patients):
Inclusion criteria (healthy control persons):
Exclusion criteria (healthy control persons):
Inclusion criteria (patients with Motor Neuron Diseases other than ALS):
Exclusion criteria (patients with Motor Neuron Diseases other than ALS):
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Regina Schlaeger, PD Dr. | Contact | 0041 61 328 67 49 | regina.schlaeger@usb.ch | |
| Janina Wendebourg, Dr. | Contact | 0041 61 556 57 99 | janina.wendebourg@usb.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39287519 | Derived | 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. |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood Samples
| baseline, months 6, 12, 18 and 24 |
| ALS Functional Rating Scale | ALS Functional Rating Scale (ALSFRS-R) | baseline, months 6, 12, 18 and 24 |
| Neurofilament Light Chain Levels | Neurofilament Light Chain Levels (pg/ml) | baseline, months 6, 12, 18 and 24 |
| Sniff nasal inspiratory pressure | Sniff nasal inspiratory pressure (SNIP) (cmH2O) | baseline, months 6, 12, 18 and 24 |
| Segmental Muscle Force | Segmental Muscle Force assessed by hand-held dynamometry (N) | baseline, months 6, 12, 18 and 24 |
| MUNIX | Motor Unit Number Index (MUNIX) in selected muscles | baseline, months 6, 12, 18 and 24 |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |