People who are diagnosed with MND often have an MRI scan of their brain and cervical cord (the part in the neck area) as part of their diagnostic work-up, to exclude other causes of their symptoms. NiSALS is an international collaboration of neuroscience centres involved in research in MND. People with MND are asked for their consent to use the MRI scans obtained at the time of diagnosis for research purposes. If they agree, the anonymised scans are sent together with standardised clinical data to an international data repository based at the University of Jena, Germany. Researchers can apply for permission to use this large data resource obtained from people with MND from many different countries to test ideas about the way the disease works. The opportunity to study large numbers of scans results in a higher change of being able to detect subtle changes of potential importance to further our understanding of how the disease works. (Recruiting at Sheffield)
|Study title||Contributing clinical MRI scans to multi-centre collaboration|
|UK Chief Investigator||Professor Dame Pamela Shaw|
|Research summary||When patients are diagnosed with motor neuron disease in our hospital, they will have detailed MRI scans of the brain and upper spinal cord to make sure that no other conditions could be mimicking motor neuron disease. This is a standard part of their normal clinical care. We would like to ask permission from each person to send their scans, in anonymised form, to neurologist colleagues in Europe (the NiSALS consortium) who are organising a large database of scans of patients with motor neuron disease from many different countries. The aim is to find similarities in scan appearances from this big group which could help make the diagnosis earlier, monitor disease progression, and help predict the course of the disease. In order for the protocol to be the same for all scans and across centres, it may require a few minutes longer in the scanner. In addition, we would like to send anonymised clinical data (for example, MRC power scores, type of disease onset) from the time of scan acquisition.|
|Inclusion/exclusion criteria||INCLUSION CRITERIA
- Age over 18.
- Undergoing clinical investigation for a diagnosis of motor neuron disease.
- Neurologically healthy.
- Co-existent other central nervous system disease.
- Cognitive impairment impairing ability to give informed consent.
- Pacemakers or other contraindications to magnetic resonance imaging.
- Forced vital capacity of less than 60% at inclusion or other evidence of respiratory failure (as this might affect their ability to lie flat comfortably in the MR scanner) .
|Current status||Recruitment on hold|
|Recruitment group(s)||Participant groups:
1. Patients with MND
2. Patients with other neurological conditions (disease controls)
3. Neurologically healthy volunteers
|Recruitment target(s)||300 participants.|
|Key dates||Study start date: 10 October 2013
Planned recruitment end date: 31 December 2025
|Funder(s)||Medical Research Council|
|Sponsor||Sheffield Teaching Hospitals NHS Foundation Trust|
|Study design||Cohort observational|
|Intervention (if applicable)||Not applicable|
|Phase (if applicable)||Not applicable|
|Outcome measures||The purpose of this study is to collate a clinical and MRI data resource. Participating studies may submit research proposals to the custodians of the NiSALS database.|
|Publications / Results reports||Links will be provided when papers are published.|
|Participant Information Sheet|