Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

March 3, 2026 updated by: University Hospital, Basel, Switzerland

Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences: A Pilot Study

This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

An averaged magnetization inversion recovery acquisitions (AMIRA) sequence was proposed for SC MRI. This MR-sequence delivers excellent contrast between the SC gray and white matter as well as between the SC and cerebrospinal fluid (CSF) in clinically feasible-acquisition times. Moreover, the high quality and in-plane resolution of AMIRA images allows for segmentation of the SC gray and white matter with high accuracy and reproducibility. This study is to evaluate the sensitivity and intra-/inter-observer agreement of the averaged magnetization inversion recovery acquisitions (AMIRA) in spinal cord (SC) Multiple sclerosis (MS) lesion detection and to evaluate the additional clinical value of this sequence in clinical settings.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Katrin Parmar, PD Dr. med.
        • Sub-Investigator:
          • Charidimos Tsagkas, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of multiple sclerosis according to established international criteria
  • Steroid free period: > 4 weeks
  • Participation in the Swiss MS Cohort (SMSC) study

Exclusion Criteria:

  • . History of severe (other) neurological, internal or psychiatric disease with SC affection

  • MRI-related exclusion criteria (questionnaire):

    1. Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
    2. Pacemaker
    3. Claustrophobia
    4. Pregnancy, lactation
    5. Known hypersensitivity to gadolinium-based contrast media

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal Cord MRI
Procedure: SC MRI
SC MRI (Averaged Magnetization Inversion Recovery Acquisitions (AMIRA), standard conventional SC MRI sequences, additional sequences for spinal cord MRI (sagittal-2D or 3D short tau inversion recovery, sagittal-2D or 3D phase-sensitive inversion recovery, 3D magnetization prepared 2 rapid acquisition gradient echoes (MPRAGE)). To evaluate the presences of ongoing inflammation (acute or chronic) in the SC of patients, 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) will be acquired.
Other: patient questionnaire
12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of SC lesions
Time Frame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Number of SC lesions using AMIRA compared to gold-standard conventional SC MRI sequences
one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Inter-observer agreement on SC lesion count
Time Frame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Inter-observer agreement with regard to lesion detection using AMIRA compared to gold-standard conventional SC MRI sequences.
one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Presence of ongoing inflammation (acute or chronic) in the SC
Time Frame: one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)
Presence of ongoing inflammation (acute or chronic) in the SC 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight)
one time assessment (60 minutes scheduled per patient for the MRI part including preparation time outside of the scanner and actual scanning time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Freie Akademische Gesellschaft Basel

Investigators

  • Principal Investigator: Katrin Parmar, PD Dr. med., University Hospital Basel, Department of Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00269; ko21Parmar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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