ALS Spinal Cord Gray and White Matter Study

NCT05764434 | Unknown

• 1 other identifier: ALS_SC_MRI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Spinal Cord Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (7)

• Spinal Cord White Matter

  baseline, months 6, 12, 18 and 24

• Spinal Cord Total Area

  baseline, months 6, 12, 18 and 24

• ALS Functional Rating Scale

  baseline, months 6, 12, 18 and 24

• Neurofilament Light Chain Levels

  baseline, months 6, 12, 18 and 24

• Sniff nasal inspiratory pressure

  baseline, months 6, 12, 18 and 24

Study Arms (3)

Patients with Amyotrophic Lateral Sclerosis

Patients with a possible, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis according to the El Escorial Criteria.

Diagnostic Test: Magnetic Resonance Imaging

Healthy Control Persons

Healthy control persons matching the ALS patient group in sex and age

Diagnostic Test: Magnetic Resonance Imaging

Patients with other Motor Neuron Diseases

Patients with Motor Neuron Diseases other than ALS

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

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

Healthy Control Persons; Patients with Amyotrophic Lateral Sclerosis; Patients with other Motor Neuron Diseases

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years or older
• neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria
• at baseline: able to lie in an MRI scanner for one hour

You may not qualify if:

• active other neurological or neuromuscular condition explaining the symptoms or a significant part of it
• other neurological or neuromuscular conditions interfering with the examinations
• 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
• other severe chronic disease
• pregnancy
• general contraindications against MRI scanning (e.g. metal implants, pacemakers)
• not able to read the patient information due to language barriers (patient information in English and French may be provided)
• major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel
• years or older
• able to lie in MRI scanner for one hour
• neurological or neuromuscular conditions
• other severe chronic disease
• pregnancy
• general contraindications against MRI scanning (e.g. metal implants, pacemakers)
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood Samples

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 10, 2023
• Study Start: May 1, 2018
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)