Cognitive Markers in Prodromal MS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05543915|
Recruitment Status : Recruiting
First Posted : September 16, 2022
Last Update Posted : September 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: Active tDCS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Luis Fernandez||929-455-5090||Luis.Fernandez2@nyulnagone.org|
|Contact: Matthew Lustbergemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Leigh Charvet, MD|
|Principal Investigator:||Leigh Charvet, MD||NYU Langone Health|