Analysing neuroinflammation and neurodegeneration in amyotrophic lateral sclerosis: quantitative imaging in a clinical trial

Not Applicable

Completed

• Conditions: Motor neuron disease, also referred to as amyotrophic lateral sclerosis; Nervous System Diseases; Motor neuron disease

• Registration Number: ISRCTN40093015
• Lead Sponsor: CHU de Nimes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-16
• Study Completion: 2019-08-01
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Current inclusion criteria as of 24/03/2017:
For participants with MND/ALS enrolled in MIROCALS:
1. Patients of either sex
2. 18 to 75 years of age (inclusive)
3. Probable or laboratory probable, or definite ALS by El Escorial revised ALS diagnostic criteria (Brooks et al. 2000)
4. Disease duration = 24 months
5. Vital capacity = 80% of predicted
6. No prior or present Riluzole treatment
7. Patient able to provide signed informed consent
8. Patient able to lie flat in comfort for up to 50 minutes
9. No contraindication to MRI such as cardiac pacemaker
10. Able to journey to the University of Sussex campus in Falmer for the MRI scan

Previous inclusion criteria:
For participants with MND/ALS enrolled in MIROCALS:
1. Patients of either sex
2. 18 to 75 years of age (inclusive)
3. Probable or laboratory probable, or definite ALS by El Escorial revised ALS diagnostic criteria (Brooks et al. 2000)
4. Disease duration = 24 months
5. Vital capacity = 80% of predicted
6. No prior or present Riluzole treatment
7. Patient able to provide signed informed consent
8. Patient able to lie flat in comfort for up to 50 minutes
9. No contraindication to MRI such as cardiac pacemaker
10. Able to journey to the University of Sussex campus in Falmer for the MRI scan

For healthy age-matched control subjects:
1. Patient able to provide signed informed consent
2. Patient able to lie flat in comfort for up to 50 minutes
3. No contraindication to MRI such as cardiac pacemaker
4. Able to journey to the University of Sussex campus in Falmer for the MRI scan
5. No diagnosis of neurodegenerative or neurological disease

Exclusion Criteria

1. Other causes of neuromuscular weakness
2. Presence of other neurodegenerative diseases
3. Significant cognitive impairment, clinical dementia or psychiatric illness
4. Severe cardiac or pulmonary disease
5. Other diseases precluding functional assessments
6. Contraindication for lumbar puncture
7. Other life-threatening diseases
8. Documented auto-immune disorders except asymptomatic Hashimoto thyroiditis
9. Women of child-bearing age without contraception or pregnant or breastfeeding
10. Any clinically significant laboratory abnormality
11. Other concurrent investigational medications
12. Unable to take Riluzole
13. Patient unable to lie flat in comfort for up to 50 minutes for scan
14. Contraindication to MRI such as cardiac pacemaker
15. Patient unable to provide informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified