Cognitive Markers in Prodromal MS

NYU Langone Health

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Device: Active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05543915

21-01385

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 23 to 59 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Group with tDCS-MRI

Experimental group

Description:

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.

Treatment:

Device: Active tDCS

Group without tDCS- MRI

No Intervention group

Description:

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