Clinical trial NCT05764434: ALS Spinal Cord Gray and White Matter Study
Official title: Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Spinal Cord Magnetic Resonance Imaging
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Exclusion criteria (healthy control persons):

1. neurological or neuromuscular conditions
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. 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
6. 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):

1. 18 years or older
2. neurologist-confirmed Motor Neuron Disease (not ALS)
3. able to lie in MRI scanner for one hour

Exclusion criteria (patients with Motor Neuron Diseases other than ALS):

1. other severe neurologic disease
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. 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
6. not able to read the patient information due to language barriers (patient information in English and French may be provided)

Primary outcomes:
measure: Spinal Cord Gray Matter Baseline
timeFrame: baseline
measure: Spinal Cord Gray Matter 6 month follow-up
timeFrame: 6 month follow-up
measure: Spinal Cord Gray Matter 12 month follow-up
timeFrame: 12 month follow-up
measure: Spinal Cord Gray Matter 18 month follow-up
timeFrame: 18 month follow-up
measure: Spinal Cord Gray Matter 24 month follow-up
timeFrame: 24 month follow-up
Secondary outcomes:
measure: Spinal Cord White Matter
timeFrame: baseline, months 6, 12, 18 and 24
measure: Spinal Cord Total Area
timeFrame: baseline, months 6, 12, 18 and 24
measure: ALS Functional Rating Scale
timeFrame: baseline, months 6, 12, 18 and 24
measure: Neurofilament Light Chain Levels
timeFrame: baseline, months 6, 12, 18 and 24
measure: Sniff nasal inspiratory pressure
timeFrame: baseline, months 6, 12, 18 and 24
measure: Segmental Muscle Force
timeFrame: baseline, months 6, 12, 18 and 24
measure: MUNIX
timeFrame: baseline, months 6, 12, 18 and 24
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References: