Group with tDCS-MRI for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Multiple Sclerosis
Active tDCS - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Day 1 (Visit 1)

4 minutes
Cerebral metabolic rate of oxygen (CMRO2)
Day 1 (Visit 1)
BICAMS Brief Visuospatial Memory Test Revised (BVMT-R) Score
BICAMS Rey Auditory Verbal Learning Test (RAVLT) Score
Brief International Cognitive Assessment for MS (BICAMS) Symbol Digit Modalities Test (SDMT) Score
Intra-Individual Variability (IIV) as measured by Cogstate Brief Battery (CBB)
Wide Range Achievement Test- 4th Edition (WRAT-4) Reading Recognition Score

Trial Safety

Safety Progress

1 of 3

Side Effects for

Active tDCS
10%headache
10%headedness / dizziness
7%fatigue or nausea
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01649232) in the Active tDCS ARM group. Side effects include: headache with 10%, headedness / dizziness with 10%, fatigue or nausea with 7%.

Trial Design

2 Treatment Groups

Group without tDCS- MRI
1 of 2
Group with tDCS-MRI
1 of 2
Active Control
Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Group with tDCS-MRI · No Placebo Group · N/A

Group with tDCS-MRI
Device
Experimental Group · 1 Intervention: Active tDCS · Intervention Types: Device
Group without tDCS- MRINoIntervention Group · 1 Intervention: Group without tDCS- MRI · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS
2012
Completed Phase 3
~730

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 (visit 1)
Closest Location: NYU Langone Health · New York, NY
Photo of NYU Langone Health  1Photo of NYU Langone Health  2Photo of NYU Langone Health  3
2020First Recorded Clinical Trial
6 TrialsResearching Multiple Sclerosis
107 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have had a first clinically isolated syndrome or MRI-defined radiologically isolated syndrome in the past 6 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.