DECISIve - DiagnosE Using the Central veIn SIgn v1.0

NCT05533905 | Completed DMC

• 1 other identifier: 19NS022
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Is T2* MRI scan more sensitive than lumbar puncture with oligoclonal band testing for diagnosing MS at the time of first clinical presentation?

  Comparison of MRI and lumbar puncture in diagnosing MS.

  18 months

Secondary Outcomes (2)

• Is there a significant difference between the specificity of each diagnostic test in this cohort?

  18 months

• Is there a significant difference between the sensitivity and specificity of the 'rule of six' proposed in Mistry et al. 2016 and lumbar puncture with oligoclonal bands?

  18 months

Interventions

Lumbar puncture DIAGNOSTIC_TEST

A thin needle is inserted between the bones in the spine.

MRI DIAGNOSTIC_TEST

A scan of the head.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 115 participants will be recruited over 30 months across the four participating sites.

You may qualify if:

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

You may not qualify if:

• Fulfils the diagnosis of MS, as defined by the 2017 revision of McDonald diagnostic criteria (Thompson et al. 2017).
• 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.
• Unable to provide informed consent.
• Contraindication or inability to undergo MRI due to metal or metal implants, pregnancy, claustrophobia, pain, spasticity, or excessive movement related to tremor.
• 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
• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

NUH NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Spinal Puncture

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nikos Evangelou

  NUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: December 9, 2019
• Primary Completion: November 6, 2023
• Study Completion: November 6, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

GB (1)