NCT05543915

Cognitive Markers in Prodromal MS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 23 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective observational clinical study, where the researchers will recruit adults with early MS (n=60) to complete a cognitive assessment and an optional gait assessment using Runscribe and G-sensor. Thirty-five \[35\] participants will also have a single 60-minute investigational MRI combined with 20 minutes of simultaneous tDCS. The MRI will repeat the protocol from the researchers' current study (ClinicalTrials.gov Identifier: NCT03564496, IRB i18-00548) using simultaneous transcranial direct current stimulation (tDCS) during the imaging acquisition.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	Active tDCS	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.

Timeline

• Start date: 2022-02-09
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2022-09-16
• Last updated: 2025-07-14
• Results posted: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study