ALS Spinal Cord Gray and White Matter Study

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05764434
• Other study ID #: ALS_SC_MRI
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Regina Schlaeger, PD Dr.
• Phone: 0041 61 328 67 49
• Email: regina.schlaeger[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
Magnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Cord Gray Matter Baseline	Spinal cord gray matter cross-sectional area in mm2	baseline
Primary	Spinal Cord Gray Matter 6 month follow-up	Spinal cord gray matter cross-sectional area in mm2	6 month follow-up
Primary	Spinal Cord Gray Matter 12 month follow-up	Spinal cord gray matter cross-sectional area in mm2	12 month follow-up
Primary	Spinal Cord Gray Matter 18 month follow-up	Spinal cord gray matter cross-sectional area in mm2	18 month follow-up
Primary	Spinal Cord Gray Matter 24 month follow-up	Spinal cord gray matter cross-sectional area in mm2	24 month follow-up
Secondary	Spinal Cord White Matter	Spinal cord white matter cross-sectional area in mm2	baseline, months 6, 12, 18 and 24
Secondary	Spinal Cord Total Area	Total spinal cord cross-sectional area in mm2	baseline, months 6, 12, 18 and 24
Secondary	ALS Functional Rating Scale	ALS Functional Rating Scale (ALSFRS-R)	baseline, months 6, 12, 18 and 24
Secondary	Neurofilament Light Chain Levels	Neurofilament Light Chain Levels (pg/ml)	baseline, months 6, 12, 18 and 24
Secondary	Sniff nasal inspiratory pressure	Sniff nasal inspiratory pressure (SNIP) (cmH2O)	baseline, months 6, 12, 18 and 24
Secondary	Segmental Muscle Force	Segmental Muscle Force assessed by hand-held dynamometry (N)	baseline, months 6, 12, 18 and 24
Secondary	MUNIX	Motor Unit Number Index (MUNIX) in selected muscles	baseline, months 6, 12, 18 and 24