Amyotrophic Lateral Sclerosis
Conditions
Keywords
Amyotrophic Lateral Sclerosis, Spinal Cord Magnetic Resonance Imaging
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Imaging
Magnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA)
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
(patients): 1. 18 years or older 2. neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria 3. at baseline: able to lie in an MRI scanner for one hour
Exclusion criteria
(patients): 1. active other neurological or neuromuscular condition explaining the symptoms or a significant part of it 2. other neurological or neuromuscular conditions interfering with the examinations 3. 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 4. other severe chronic disease 5. pregnancy 6. general contraindications against MRI scanning (e.g. metal implants, pacemakers) 7. not able to read the patient information due to language barriers (patient information in English and French may be provided) 8. major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel Inclusion criteria (healthy control persons): 1. 18 years or older 2. able to lie in MRI scanner for one hour
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Gray Matter Baseline | baseline | Spinal cord gray matter cross-sectional area in mm2 |
| Spinal Cord Gray Matter 6 month follow-up | 6 month follow-up | Spinal cord gray matter cross-sectional area in mm2 |
| Spinal Cord Gray Matter 12 month follow-up | 12 month follow-up | Spinal cord gray matter cross-sectional area in mm2 |
| Spinal Cord Gray Matter 18 month follow-up | 18 month follow-up | Spinal cord gray matter cross-sectional area in mm2 |
| Spinal Cord Gray Matter 24 month follow-up | 24 month follow-up | Spinal cord gray matter cross-sectional area in mm2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Segmental Muscle Force | baseline, months 6, 12, 18 and 24 | Segmental Muscle Force assessed by hand-held dynamometry (N) |
| Spinal Cord White Matter | baseline, months 6, 12, 18 and 24 | Spinal cord white matter cross-sectional area in mm2 |
| MUNIX | baseline, months 6, 12, 18 and 24 | Motor Unit Number Index (MUNIX) in selected muscles |
| Spinal Cord Total Area | baseline, months 6, 12, 18 and 24 | Total spinal cord cross-sectional area in mm2 |
| ALS Functional Rating Scale | baseline, months 6, 12, 18 and 24 | ALS Functional Rating Scale (ALSFRS-R) |
| Neurofilament Light Chain Levels | baseline, months 6, 12, 18 and 24 | Neurofilament Light Chain Levels (pg/ml) |
| Sniff nasal inspiratory pressure | baseline, months 6, 12, 18 and 24 | Sniff nasal inspiratory pressure (SNIP) (cmH2O) |
Countries
Switzerland
Contacts
Primary ContactRegina Schlaeger, PD Dr.
Backup ContactJanina Wendebourg, Dr.
Outcome results
None listed