NCT02403570

Brief Summary

The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

March 10, 2015

Last Update Submit

March 2, 2021

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Keywords

Multiple Sclerosis, MRI, rotating frame

Outcome Measures

Primary Outcomes (2)

  • MR relaxation values 0

    Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS at baseline

    Baseline

  • MR relaxation values 1

    Aim is to measure different quantitative MR relaxation values (e.g. Traff, T1rho) in different brain areas of patients with MS after one year follow-up

    One year

Secondary Outcomes (2)

  • MR relaxation values and clinical markers 0

    Baseline

  • MR relaxation values and clinical markers 1

    One year

Study Arms (1)

Multiple Sclerosis

Brain MRI using advanced MR techniques

Other: Brain MRI

Interventions

Brain MRIOTHER
Multiple Sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MS patients with relapsing-remitting or secondary progressive MS will be recruited from amongst the MS patients in the neurological outpatient policlinics in the Hospital District of Southwestern Finland.

You may qualify if:

  • The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or revised McDonald's criteria (Group I) before participating in the study
  • Initial MS diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (Group II).
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

You may not qualify if:

  • Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive medication
  • High-dose corticosteroid treatment within 30 days before participating in the study
  • Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
  • Any psychiatric condition that compromises the subject's ability to participate in the study
  • Infections: Patient must not have an uncontrolled serious infection
  • No contraindications for MRI (cardiac pacemaker, intracranial clips etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Neurosciences, Turku University Hospital

Turku, FI-20520, Finland

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hannu Aronen, M.D., Ph.D.

    Turku University Hospital, Department of Diagnostic Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 31, 2015

Study Start

February 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

FI(1)