Measuring spinal cord changes in ALS patients using MRI

Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis

This study is testing a new MRI technique to see how the spinal cords of people with ALS change over time compared to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (other)
• Locations: 1 site (Basel)
• Trial ID: NCT05764434 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the spinal cord gray and white matter in individuals diagnosed with Amyotrophic Lateral Sclerosis (ALS) and healthy controls matched by age and sex. Utilizing a novel MRI technique called rAMIRA, participants will undergo MRI scans, clinical evaluations, and muscle strength tests every six months over a two-year period. Additionally, serum markers of neuro-axonal injury will be analyzed to provide insights into the disease's progression and impact. The study seeks to enhance understanding of ALS through detailed imaging and clinical assessments.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with neurologist-confirmed ALS who can tolerate MRI scanning.

Not a fit: Patients with other significant neurological or neuromuscular conditions, severe spinal issues, or contraindications to MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and monitoring techniques for ALS, potentially enhancing patient care.

How similar studies have performed: While similar imaging approaches have been explored, this specific application of rAMIRA in ALS is novel and has not been extensively tested.

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)

Where this trial is running

Basel

• University Hospital Basel — Basel, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Regina Schlaeger, PD Dr.

Conditions: Amyotrophic Lateral Sclerosis, Spinal Cord Magnetic Resonance Imaging