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NCT05543915Completed

Cognitive Markers in Prodromal MS

Intra-Individual Variability in Cognitive Performance as a Marker of Prodromal Disability in MS

Source: ClinicalTrials.gov · Last updated 14 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
60 (actual)
First submitted
13 Sept 2022
Start date
9 Feb 2022
Primary completion date
20 Jun 2024
Lead sponsor
NYU Langone Health
NCT number
NCT05543915

What you commit to

  • Study type: Interventional
  • Participants enrolled: 60
  • From 9 Feb 2022 to the primary completion date, 20 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have any irremovable piercings, metallic based-tattoos, or MRI-contraindicated implants (e.g. pacemakers and defibrillators)

Other illness

  • 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).
  • 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

Age

  • Presence of severe cognitive impairment (based on SDMT age normative z-score \<-3.0).

Other

  • Below average estimated premorbid cognitive functioning (based on WRAT-4 reading recognition standard z-score \< 85).
  • Pregnant or breastfeeding
    • Additional Exclusion Criteria for tDCS-MRI Participants
  • Extreme claustrophobia

Who the study is looking for

  • 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)

Age in the registry: 23 years to 59 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
NYU Langone Health
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.