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DECISIve - DiagnosE Using the Central veIn SIgn v1.0

CompletedN/A

Sponsor: Nottingham University Hospitals NHS Trust

Conditions: Multiple Sclerosis

Interventions: Lumbar puncture, MRI

Countries: United Kingdom

DECISIve - DiagnosE using the Central veIn SIgn. A prospective diagnostic superiority study comparing T2\* MRI and lumbar puncture in patients presenting with possible Multiple Sclerosis

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Presentation with a typical clinically isolated syndrome (Thompson et al. 2017) for diagnostic evaluation of MS.

Exclusion Criteria:

1. Fulfils the diagnosis of MS, as defined by the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2017).
2. Unwilling or unable to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that, in the opinion of the PI, is likely to affect the participant's ability to comply with the study protocol.
3. Unable to provide informed consent.
4. Contraindication or inability to undergo MRI due to metal or metal implants, pregnancy, claustrophobia, pain, spasticity, or excessive movement related to tremor.
5. Acute COVID-19 infection at time of face-to-face interactions during study (unless investigations can be delayed until considered safe by the responsible clinician and PI) either diagnosed clinically or by acute infection testing
6. Participant required to self-isolate at time of face-to-face interactions during study (unless investigations can be delayed until considered safe by the responsible clinician and PI) due to COVID-19 exposure, shielding due to medical advice, public health advice or governmental advice/laws.

Locations (1)

Nottingham, United Kingdom