MRI methods development for cerebrospinal MRI
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (i) Healthy adults without neurological diseases (ii) Patients with Multiple Sclerosis with at leas one spinal cord leasion (known from previous examinations) • capacity to consent • written informed consent after comprehensive explanation
Exclusion criteria
Exclusion criteria: • Individuals unable to provide written informed consent • History of psychiatric or neurological disorders (first phase) • Severe internal or systemic disease • Contraindications to MRI (e.g., pacemakers, artificial heart valves, Cardioseal, aneurysm clips, implanted magnetic metal components [screws, plates from surgeries], cochlear implants, metal or grenade fragments, acupuncture needles, insulin pumps, non-removable piercings, claustrophobia, etc.) • Pregnancy • Carotid artery stents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not directly applicable to this type of study. The success of the study and the achievement of the primary/secondary objectives will be assessed based on the following criteria: • Reduction of acquisition time: Comparable or improved image quality with reduced acquisition time compared to the respective non-optimized, original imaging method. Image quality should be assessed both visually and quantitatively (e.g., using the Structural Similarity Index and similar metrics). • Optimization of other imaging parameters and the use of motion correction and magnetic field homogenization techniques: Improved image quality and reduced impact of motion- and susceptibility-induced image artifacts compared to the respective non-optimized, original imaging method. Image quality should be assessed both visually and quantitatively (e.g., using the Structural Similarity Index and similar metrics). • Quantification of tissue properties: Agreement of measured parameter values (T1, T2, T2*, susceptibility, MT, diffusivity, and perfusion or blood-brain barrier permeability) in the healthy human brain and spinal cord with known literature values. • Diagnostic suitability: Agreement and reliability in the depiction of pathological anomalies (e.g., MS lesions) in the human brain and spinal cord of MS patients compared to clinically established imaging methods. • Quantification of tissue properties in patients: Agreement of measured parameter values or the trend of deviation (T1, T2, T2*, PD, susceptibility, MT, diffusivity, and perfusion or blood-brain barrier permeability) in the human brain and spinal cord with known literature values for MS patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not directly applicable to this type of study. See Primary outcome. | — |
Countries
Germany
Contacts
Institut für Neuroradiologie, TUM Universitätsklinikum, Klinikum rechts der Isar, Technische Universität München