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Spinal Cord Lesion Detection in Multiple Sclerosis Using Novel MRI Sequences

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04819737
Enrollment
10
Registered
2021-03-29
Start date
2022-07-18
Completion date
2027-12-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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.

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.

Interventions

PROCEDURESC 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.

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

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER
Freie Akademische Gesellschaft Basel
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of SC lesionsone 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
Inter-observer agreement on SC lesion countone 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.
Presence of ongoing inflammation (acute or chronic) in the SCone 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)

Countries

Switzerland

Contacts

CONTACTKatrin Parmar, PD Dr. med.
katrin.parmar@unibas.ch+41 61 83 65 214
CONTACTCharidimos Tsagkas, Dr. med.
charidimos.tsagkas@usb.ch
PRINCIPAL_INVESTIGATORKatrin Parmar, PD Dr. med.

University Hospital Basel, Department of Neurology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026