Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

NCT04819737 | Recruiting

• 1 other identifier: 2021-00269; ko21Parmar
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis (MS)

Keywords

spinal cord (SC) pathology; demyelinating lesions; Spinal cord MRI; Averaged magnetization inversion recovery acquisitions (AMIRA) sequence; Swiss MS Cohort (SMSC)

Outcome Measures

Primary Outcomes (3)

• Number of SC lesions

  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

  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

  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)

Study Arms (1)

Spinal Cord MRI

EXPERIMENTAL

Procedure: SC MRI; Other: patient questionnaire

Interventions

SC MRI PROCEDURE

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.

Spinal Cord MRI

patient questionnaire OTHER

12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability

Spinal Cord MRI

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• History of severe (other) neurological, internal or psychiatric disease with SC affection
• Paramagnetic and/or superparamagnetic foreign objects in the body (especially when located close to the SC)
• Pacemaker
• Claustrophobia
• Pregnancy, lactation
• Known hypersensitivity to gadolinium-based contrast media

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Freie Akademische Gesellschaft Basel: collaborator

Study Sites (1)

University Hospital Basel, Department of Neurology

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Patient Health Questionnaire

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)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Katrin Parmar, PD Dr. med.

  University Hospital Basel, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Parmar, PD Dr. med.

CONTACT

+41 61 83 65 214; katrin.parmar@unibas.ch

Charidimos Tsagkas, Dr. med.

CONTACT

charidimos.tsagkas@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants (embedded within the currently ongoing Swiss MS Cohort (SMSC) study) will undergo a single visit including a clinical interview, neurological examination and MRI.

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: July 18, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CH (1)