ALS Spinal Cord Gray and White Matter Study

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT05764434
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2025-05-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Baseline	baseline	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
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

Secondary Outcome Measures

Name	Time	Method
MUNIX	baseline, months 6, 12, 18 and 24	Motor Unit Number Index (MUNIX) in selected muscles
Sniff nasal inspiratory pressure	baseline, months 6, 12, 18 and 24	Sniff nasal inspiratory pressure (SNIP) (cmH2O)
Segmental Muscle Force	baseline, months 6, 12, 18 and 24	Segmental Muscle Force assessed by hand-held dynamometry (N)
Spinal Cord Total Area	baseline, months 6, 12, 18 and 24	Total spinal cord cross-sectional area in mm2
Spinal Cord White Matter	baseline, months 6, 12, 18 and 24	Spinal cord white matter 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)

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland