Motor neuron disease, also referred to as amyotrophic lateral sclerosis Nervous System Diseases Motor neuron disease
Conditions
Interventions
Current interventions as of 24/03/2017:
The “Analysing Neuroinflammation and Neurodegeneration in Amyotrophic Lateral Sclerosis (ALS): Quantitative Imaging in a Clinical Trial” (ANNALS
quantitative magnetisation transfer (qMT) imaging which provides measures primarily about nerve cell insulation (myelin) content and composition
and resting state functional MRI (rsfMRI) to study the degreeto which brain regions communicate at rest.
The principal brain regions of interest for analysis will be the brain surface
Sponsors
CHU de Nimes
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 24/03/2017: Quantitative magnetic resonance brain imaging data within the primary motor cortices, corticospinal tracts, corpus callosum and resting state sensorimotor network at baseline obtained by: 1. NODDI (including the Orientation Dispersion Index [ODI], Neurite Density Index [NDI], Isotropic Volume Fraction [ISO]) 2. qMTi (including the f-value, kf value and T2f relaxation time) 3. rsfMRI (primarily the resting state sensorimotor network) Previous primary outcome measures: Quantitative multimodal magnetic resonance brain imaging data, obtained by: 1. NODDI (including the Orientation Dispersion Index [ODI], Neurite Density Index [NDI], Isotropic Volume Fraction [ISO]) 2. qMTi (including the f-value, kf value and T2f relaxation time) 3. rsfMRI (using fluctuations in BOLD signal) within the primary motor cortices, corticospinal tracts and resting state sensorimotor network at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/03/2017: Quantitative magnetic resonance brain imaging data within brain areas other than the primary motor cortices, corticospinal tracts, corpus callosum and resting state sensorimotor network at baseline obtained by: 1. NODDI (including the Orientation Dispersion Index [ODI], Neurite Density Index [NDI], Isotropic Volume Fraction [ISO]) 2. qMTi (including the f-value, kf value and T2f relaxation time) 3. rsfMRI (other resting state networks such as the default mode network and frontoparietal network) Previous secondary outcome measures: Quantitative multimodal magnetic resonance brain imaging data, obtained by: 1. NODDI (including the Orientation Dispersion Index [ODI], Neurite Density Index [NDI], Isotropic Volume Fraction [ISO]) 2. qMTi (including the f-value, kf value and T2f relaxation time) 3. rsfMRI (using fluctuations in BOLD signal) within brain areas other than the primary motor cortices, corticospinal tracts and resting state sensorimotor network at baseline | — |
Countries
United Kingdom
Outcome results
None listed