Cognitive Markers in Prodromal MS
Intra-Individual Variability in Cognitive Performance as a Marker of Prodromal Disability in MS
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Active tDCS
Results by group
Cerebral Metabolic Rate of Oxygen (CMRO2)
Day 1 (Visit 1 - approximately 4 minutes)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Group With tDCS-MRI | 8.17 micro-mol/100g/min | 12.99 (Standard Deviation) | 29 |
Intra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB)
Day 1 (Visit 1)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Group With tDCS-MRI | 0.37 log10(ms) | 0.64 (Standard Deviation) | 30 |
| Group Without tDCS- MRI | 0.34 log10(ms) | 0.64 (Standard Deviation) | 29 |
Group With tDCS-MRI
Group Without tDCS- MRI
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Group With tDCS-MRI | 30 | 0 (0.0%) | 0 |
| Group Without tDCS- MRI | 29 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Cerebral Metabolic Rate of Oxygen (CMRO2)
Day 1 (Visit 1 - approximately 4 minutes)
MRI lesionsIntra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB)
Day 1 (Visit 1)
Other measures (3)
Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Z-Score
Day 1 (Visit 1)
Thinking and memoryBICAMS Rey Auditory Verbal Learning Test (RAVLT) Z-Score
Day 1 (Visit 1)
Thinking and memoryBICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Z-Score
Day 1 (Visit 1)
Thinking and memory
Who could take part
Early (CIS/RIS) · 23 to 59
Show the full criteria
Inclusion criteria
* Ages 23-59 years old (inclusive) * Prodromal MS (defined by radiologically isolated syndrome ≤ 6 months from first MRI or clinically isolated syndrome ≤ 3 months from first clinical event)
Exclusion criteria
* Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score \< 85). * Presence of severe cognitive impairment (based on SDMT age normative z-score \<-3.0). * Primary psychiatric disorder that would influence ability to participate. * Current uncontrolled seizure disorder. * Current substance abuse disorder. * History of head trauma in the past year (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator). * Pregnant or breastfeeding Additional Exclusion Criteria for tDCS-MRI Participants * Extreme claustrophobia * Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed) * Treatment for a communicable skin disorder currently or over the past 12 months * Have any irremovable piercings, metallic based-tattoos, or MRI-contraindicated implants (e.g. pacemakers and defibrillators)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The focus of this work is the evaluation of a measure of cognitive functioning- intra-individual variability (IIV) - derived from a computer-based continuous reaction time (RT) task (Cogstate) as an early marker of prodromal MS.
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History
Started
Feb 2022
Main results due
Jun 2024
Finished
Jun 2024
Results posted
Jul 2025