Trial results for a study investigating cognitive markers in prodromal Multiple Sclerosis were posted on ClinicalTrials.gov on 2025-07-14, with 60 participants enrolled.
Background
Multiple Sclerosis (MS) is a chronic, often debilitating disease that affects the brain and spinal cord. Early identification of the disease, particularly in its prodromal phase, is crucial for timely intervention and potentially slowing disease progression. This study focused on evaluating cognitive functioning, specifically intra-individual variability (IIV) derived from a computer-based continuous reaction time task, as an early marker for prodromal MS. Understanding such markers could aid in earlier diagnosis and monitoring of the disease.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants to investigate Multiple Sclerosis. The primary focus of the work was the evaluation of intra-individual variability (IIV) as a measure of cognitive functioning, derived from a computer-based continuous reaction time task (Cogstate), as an early marker of prodromal MS.
Key results
The trial reported several key measurements related to cognitive markers:
- Cerebral Metabolic Rate of Oxygen (CMRO2):
- For the Group With tDCS-MRI, the mean was 8.17 micro-mol/100g/min (Standard Deviation 12.99).
- Intra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB):
- For the Group With tDCS-MRI, the mean was 0.37 log10(ms) (Standard Deviation 0.64).
- For the Group Without tDCS- MRI, the mean was 0.34 log10(ms) (Standard Deviation 0.64).
- Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Z-Score:
- For the Group With tDCS-MRI, the mean was -1.09 Z-score (Standard Deviation 1.25).
- For the Group Without tDCS- MRI, the mean was -1.03 Z-score (Standard Deviation 1.28).
- BICAMS Rey Auditory Verbal Learning Test (RAVLT) Z-Score:
- For the Group With tDCS-MRI, the mean was -0.17 Z-score (Standard Deviation 0.87).
- For the Group Without tDCS- MRI, the mean was -0.25 Z-score (Standard Deviation 0.91).
- BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Z-Score:
- For the Group With tDCS-MRI, the mean was 0.14 Z-score (Standard Deviation 1.33).
- For the Group Without tDCS- MRI, the mean was -0.02 Z-score (Standard Deviation 0.85).
What this means
The posted results provide specific measurements for various cognitive markers, including intra-individual variability (IIV), cerebral metabolic rate of oxygen (CMRO2), and components of the Brief International Cognitive Assessment for MS (BICAMS), in the context of prodromal Multiple Sclerosis. The data includes mean values and standard deviations for these markers across different study groups. These findings contribute to the characterization of cognitive profiles in individuals potentially in the early stages of MS, which could be valuable for developing tools for early detection and monitoring disease progression. No comparative analyses or statements of statistical significance were provided in the posted results.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05543915, titled "Cognitive Markers in Prodromal MS", were posted on 2025-07-14 on clinicaltrials.gov.