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Cognitive Markers in Prodromal MS

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ClinicalTrials.gov Identifier: NCT05543915
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : September 16, 2022
National Multiple Sclerosis Society
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Active tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Intra-Individual Variability in Cognitive Performance as a Marker of Prodromal Disability in MS
Actual Study Start Date : January 18, 2022
Estimated Primary Completion Date : June 18, 2024
Estimated Study Completion Date : June 18, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group with tDCS-MRI
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
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.

No Intervention: Group without tDCS- MRI
Participants will have include a cognitive assessment and an optional gait assessment

Primary Outcome Measures :
  1. Cerebral metabolic rate of oxygen (CMRO2) [ Time Frame: 4 minutes ]
    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.

  2. Intra-Individual Variability (IIV) as measured by Cogstate Brief Battery (CBB) [ Time Frame: Day 1 (Visit 1) ]
    The core Cogstate 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.

Secondary Outcome Measures :
  1. Wide Range Achievement Test- 4th Edition (WRAT-4) Reading Recognition Score [ Time Frame: Day 1 (Visit 1) ]
    WRAT-4 is a brief test of single word reading recognition that provides a proxy of literacy and general intellectual ability. Standard scores for the WRAT-4 subtests range from a low of 55 to a high of 145. The higher the score, the higher the level of literacy and general intellectual ability.

  2. Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Score [ Time Frame: Day 1 (Visit 1) ]
    SDMT is 90-second cognitive task in which the participant is shown a sheet containing rows of symbols. Each symbol corresponds to a specific number. The participant's task is to say out loud the number associated with each symbol. SDMT is used as a general cognitive screen to detect severe cognitive impairment. The final score is the correct number of substitutions in 90 seconds, scores range between 0 and 110. The lower the score, the more severe the cognitive impairment.

  3. BICAMS Rey Auditory Verbal Learning Test (RAVLT) Score [ Time Frame: Day 1 (Visit 1) ]
    RAVLT is a well-recognized measure of a person's ability to encode, combine, store and recover verbal information in different stages of immediate memory. consists of presenting a list of 15 words across consecutive trials. The list is read aloud to the participant, and then the participant is immediately asked to recall as many words as one remembers. This procedure is repeated for 5 consecutive trials (Trials 1 to 5). The total score is the sum of trials 1-5 and ranges from 0-75. The lower the score, the more severe the cognitive impairment.

  4. BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Score [ Time Frame: Day 1 (Visit 1) ]
    Visual/spatial memory is assessed in BICAMS using the BVMT-R. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three Learning Trials, and the score is reported as the total number of points earned over the trials. Thus, scores range from 0 to 12 per trial; total score range is 0 to 36 for all three trials. The lower the score, the more severe the cognitive impairment.

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05543915

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Contact: Luis Fernandez 929-455-5090 Luis.Fernandez2@nyulnagone.org
Contact: Matthew Lustberg matthew.luistberg@nyulangone.org

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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Luis Fernandez    929-455-5090    Luis.Fernandez2@nyulnagone.org   
Contact: Matthew Lustberg       matthew.lustberg@nyulangone.org   
Principal Investigator: Leigh Charvet, MD         
Sponsors and Collaborators
NYU Langone Health
National Multiple Sclerosis Society
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Principal Investigator: Leigh Charvet, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05543915    
Other Study ID Numbers: 21-01385
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases