Cognitive Markers in Prodromal MS

NCT05543915 | Completed Results DMC FDA Device

• 1 other identifier: 21-01385
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Cerebral Metabolic Rate of Oxygen (CMRO2)

  CMRO2 is the amount of O2 the brain consumes per unit of time (in μmol O2/100g tissue per minute). To quantify absolute CMRO2, both TRUST MRI for quantification of venous oxygenation (Yv) and phase contrast (PC) MRI for quantification of total blows are needed. The total scan time for CMRO2 MRI is approximately 4 minutes.

  Day 1 (Visit 1 - approximately 4 minutes)

• Intra-Individual Variability (IIV) as Measured by Cogstate Brief Battery (CBB)

  The core Cogstate Reaction Time (RT) tasks involve a deck of cards on a green background screen and the participant answers "yes" or "no" by hitting a keyboard key ("D" or "K") across repeated trials. Each task first includes instructions and practice period before the test begins and takes approximately 3-4 minutes to complete (for a total of \~7 minutes). The representative timed RT scores are provided by the Detection task (indicating when a card is revealed; DET/simple RT), Identification task ("is the card revealed black or red?"; IDN/choice RT), and One-Back ("Is this the card that you just saw?"). Performance is characterized by near complete accuracy (i.e. all, or almost all, items are answered correctly), and validity checks are built into the scoring. IIV is calculated as intraindividual standardized deviations (ISD) in RTs across both tasks, measured in milliseconds and with log10 transformation.

  Day 1 (Visit 1)

Secondary Outcomes (3)

• Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Z-Score

  Day 1 (Visit 1)

• BICAMS Rey Auditory Verbal Learning Test (RAVLT) Z-Score

  Day 1 (Visit 1)

• BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Z-Score

  Day 1 (Visit 1)

Study Arms (2)

Group with tDCS-MRI

EXPERIMENTAL

Participants will have a cognitive assessment, an optional gait assessment, and a 1-hour MRI brain scan combined with 20 minutes of simultaneous tDCS. Participants may also complete the MRI on a separate visit.

Device: Active tDCS

Group without tDCS- MRI

NO INTERVENTION

Participants will have include a cognitive assessment and an optional gait assessment

Interventions

Active tDCS DEVICE

The tDCS-MRI scan will last approximately one hour. The first 20 minutes of the MRI will not include tDCS stimulation. After 20 minutes, the tDCS device will ramp up to 2.0mA and deliver 2.0mA for 20 minutes. Then the tDCS will ramp down (30 seconds) and the final 20 minutes will be without stimulation.

Group with tDCS-MRI

Eligibility Criteria

• Age: 23 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Guiseppina Pilloni
• Organization: NYU Langone Health

giuseppina.pilloni@nyulangone.org

646-501-9274

Study Officials

• Leigh Charvet, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: February 9, 2022
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)