NCT01805986

Brief Summary

Magnetization transfer imaging is a magnetic resonance technique that has been used over the last few years, and known for its ability to detect abnormalities that can be difficult to detect by conventional MRI techniques. The investigators would like to test if using an 7 Tesla MRI research scanner can help us diagnose Multiple Sclerosis more efficiently compared to the current clinical practice, i.e. if Multiple Sclerosis lesions in Gray Matter can be more readily identified and associated with disease stage on Magnetic Transfer MRI images as opposed to conventional procedures. Image analysis will allow the investigators to perform lesion segmentation and sequence comparison between different MRI techniques. The investigators will apply computation techniques to measure the local cortical thickness. Repeated scans at 6 monthly intervals over two years will give an insight into the changes in cortical thickness over time. Based on obtained data the investigators will look for the relationship between lesion loads in White Matter and Gray Matter, cortical thickness and disease stage.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

March 5, 2013

Last Update Submit

May 16, 2013

Conditions

Keywords

Multiple Sclerosis, other neurological conditions

Outcome Measures

Primary Outcomes (1)

  • The number of Gray Matter lesions detected using different sequences.

    2 years

Secondary Outcomes (4)

  • Comparison of MRI sequencies

    2 years

  • To determine the relationship between cortical thickness as measured on T1 weighted images and GM and WM lesion load.

    2 years

  • Regional variation in the brain

    2 years

  • To detect cortical variations in MT inside and outside GM lesions, in a longitudinal pilot study, reflecting possible cortical remyelination.

    2 years

Study Arms (1)

MS patient

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients studied will be those with known MS. For purposes of comparison as described previously, we will also seek to include healthy volunteers.

You may qualify if:

  • Patients with MS or other neurological disease which already had at least 1 MRI scan.
  • Healthy volunteers which had no indication of neurological disease in the past.
  • Do not have significant cognitive impairment and are able to give consent.
  • Will not have any contraindication for MR imaging
  • Are able to lie flat for up to 60 mins.
  • Age 25 and over.

You may not qualify if:

  • Pregnancy
  • Have any implants in the body.
  • Have aneurysm clips.
  • Have pacemaker or artificial heart valve.
  • Have foreign bodies in their body (e.g. shrapnel).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nikos Evangelou, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 6, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2015

Last Updated

May 17, 2013

Record last verified: 2013-05