Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

NCT ID: NCT04819737

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis (MS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Spinal Cord MRI

Group Type EXPERIMENTAL

SC MRI

Intervention Type 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.

patient questionnaire

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Freie Akademische Gesellschaft Basel

UNKNOWN

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrin Parmar, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Department of Neurology

Locations

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University Hospital Basel, Department of Neurology

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Katrin Parmar, PD Dr. med.

Role: CONTACT

+41 61 83 65 214

Charidimos Tsagkas, Dr. med.

Role: CONTACT

Facility Contacts

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Katrin Parmar, PD Dr. med.

Role: primary

Other Identifiers

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2021-00269; ko21Parmar

Identifier Type: -

Identifier Source: org_study_id

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