N/A
N=60
Cognitive Markers in Prodromal MS
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT05543915 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Cerebral Metabolic Rate of Oxygen (CMRO2) — 8.17 micro-mol/100g/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active tDCS (Device)
- Age
- Adult · 23+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cerebral Metabolic Rate of Oxygen (CMRO2) |
8.17 | — |
| PRIMARY Intra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB) |
0.37; 0.34 | — |
| SECONDARY Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Z-Score |
-1.09; -1.03 | — |
| SECONDARY BICAMS Rey Auditory Verbal Learning Test (RAVLT) Z-Score |
-0.17; -0.25 | — |
| SECONDARY BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Z-Score |
0.14; -0.02 | — |
Summary
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT05543915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.