About this trial
This project is to:
1. Quantify differences in axonal integrity and organization in aMS versus naPMS patients. 2. Quantify changes in axonal integrity and organization in aMS versus naPMS patients over a two-year period. 3. Validate the combination of imaging parameters that best differentiate aMS versus naPMS patients using histopathology.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
active RRMS (n=100): Relapsing-remitting course and > 1 clinical relapse and/or signs of MRI activity (> 1 Gd enhancing lesion) during the last year before study enrollment.
non-active PMS (n=100): Progressive course (PPMS or SPMS) and no clinical relapses and/or signs of MRI activity during the last year before study enrollment.
Age 18-80 years old
No other neurological or psychiatric disorder
Disqualifiers
Pregnancy
Contraindication to MRI (eg, claustrophobia, metallic implants, pacemaker etc).
Inability to give consent
Trial population
The recruitment of MS patients will take place at the MS Clinic of the Department of Neurology (Neurologische Klinik und Poliklinik), University Hospital Basel (Universitätsspital Basel). Healthy subjects will be recruited by public announcements (i.e. advertisement/flyer) on the University Hospital's and the University's notice board.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI
Diagnostic testEach enrolled subject will undergo a MRI at baseline and a second MRI at 2 years (+/- 3 months) follow-up.
Neurocognitive examination for healthy subjects
Other interventionNeurocognitive examination for healthy subjects will be performed at both baseline and follow-up
blood sampling
Other interventionEach enrolled subject will undergo a blood sampling (10 ml) at baseline
Treatment groups
Trial outcomes
Primary outcomes
MRI- change in axonal integrity and organization over 2 years in aMS, naPMS and HC, by using machine learning techniques
After magnetic resonance (MR) data preprocessing (image denoising, standardization, bias field correction) classical machine learning techniques will be used to classify a number of MRI metrics which will be averaged over a number of regions of interest (ROIs) including (i) normal-appearing white and brain matter in brain lobes and cervical spinal cord, (ii) basal ganglia, (iii) thalamus, (vi) cerebellum, MS lesions. Complex input data (voxels/patches) will be generated to learn from, then a deep learning model for supervised classification will be defined to identify the combination of aMRI parameters that characterize aMS, naPMS and HC.
Secondary outcomes
Change in MUSIC Test
Neurocognitive examination. MUSIC is a rapid (about 10-12 min) multiple domain cognitive screening test reflecting the most frequently impaired cognitive domains in MS. At 20-30 points the performance is in the normal range, at 16-19 points there is at most slight cognitive dysfunction, at 11-15 points there is moderate cognitive dysfunction and at \<= 10 points there is a clear cognitive dysfunction.
Change in auditory verbal learning and memory test/ Verbaler Lern- und Merkfähigkeitstest (VLMT)
Questionnaire to investigate memory performance, learning and recall information. Five presentations of a 15-word list are given, each followed by attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested.
Change in Symbol Digital Modalities Test (SDMT)
The SDMT detects cognitive impairment by measuring the time to pair abstracts. Using a reference key, the test taker has 90 seconds to pair specific numbers with given geometric figures.
Change in Brief Visuospatial Memory Test (BVMT)
The BVMT measures visuospatial memory In three Learning Trials, the respondent views the stimulus page for 10 seconds and is asked to draw as many of the figures as possible in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Last, a Recognition Trial, in which the respondent is asked to identify which of 12 figures were included among the original geometric figures, is administered. Slower processing speed is associated with poorer learning and memory performance.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Swiss National Science Foundation
Collaborator