NCT03653585: CLiMS

Cortical Lesions in Patients With Multiple Sclerosis

Completed Last updated 8 April 2021

What this trial tests

trial in Multiple Sclerosis in 80 participants. Completed in 3 September 2020.

Timeline

4 September 2018

Primary endpoint
3 September 2020

3 September 2020

Quick facts

Lead sponsor	Danish Research Centre for Magnetic Resonance
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	4 September 2018
Primary completion	3 September 2020
Estimated completion	3 September 2020
Sites	1 location across Denmark

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
• Multiple Sclerosis, Secondary Progressive — all drugs for Multiple Sclerosis, Secondary Progressive →

Sponsor

Danish Research Centre for Magnetic Resonance

Who can join

Adults 18 to 80, any sex, with Multiple Sclerosis or Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple sclerosis (MS) is an autoimmune disease, leading to inflammation and degeneration of neurons in the entire central nervous system (CNS). Not only does MS attack CNS white matter, the wiring of the brain, but it also affects so called grey matter, involved in communication between brain cells. Some studies have shown that grey matter damage and lesions to the outermost layer of the brain, the cortex, might serve as a better diagnostic and prognostic tool for MS patients. The issue is that cortical lesions only to a limited extent can be visualized by conventional magnetic resonance imaging (MRI) at 3 tesla. The new generation of ultra-high field MR scanners with a field strength of 7 tesla, has a higher sensitivity towards detecting these cortical lesions. We therefore wish to use the improved sensitivity of ultra-high field MRI to improve detection of cortical lesions, and to elucidate the detrimental effects of single lesions to the cortex, thereby improving both diagnosis and prognosis of the disease.

By implementing newly developed ultra-high-resolution MR-sequences the amount and extent of cortical lesions to the area of the brain responsible of the sensory and motor function of the hand (sensorimotor hand area - SM1-HAND) will be investigated in patients with relapsing remitting and secondary progressive MS. We will also assess how these lesions affect manual dexterity and sensory function and how cortical lesions affect communication within brain areas. It is hypothesized that the amount and size of cortical lesions is highly involved in brain communication and manual function, a major problem in MS, and that this project will shed new light on how the disease damages this important brain area.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Linking lesions in sensorimotor cortex to contralateral hand function in multiple sclerosis: a 7 T MRI study.
   Madsen MAJ, Wiggermann V, Marques MFM, Lundell H, et al · · 2022 · cited 14× · PMID 35653498 · DOI 10.1093/brain/awac203
2. Association of Cortical Lesions With Regional Glutamate, GABA, <i>N</i>-Acetylaspartate, and Myoinositol Levels in Patients With Multiple Sclerosis.
   Madsen MA, Považan M, Wiggermann V, Lundell H, et al · · 2024 · cited 3× · PMID 38870443 · DOI 10.1212/wnl.0000000000209543
3. Delayed transcallosal conduction to the lesioned sensorimotor cortex in multiple Sclerosis: A combined TMS 7 T-MRI study.
   Madsen MAJ, Christiansen L, Wiggermann V, Lundell H, et al · · 2026 · PMID 42166849 · DOI 10.1016/j.nicl.2026.104006
4. Linking cortical lesions to metabolic changes in multiple sclerosis using 7T proton MR spectroscopy
   Madsen MAJ, Považan M, Wiggermann V, Lundell H, et al · · 2023 · DOI 10.1101/2023.08.18.23294260