An interventional study of Real tDCS + CCT and Sham tDCS + CCT in Multiple Sclerosis, Relapsing-Remitting, sponsored by University of Milano Bicocca. Withdrawn at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by University of Milano Bicocca · Not applicable, Interventional, and Treatment
Expected results: an improvement in cognitive performance in both groups, boosted in the experimental arm and not confined to general frontal-cognitive abilities; potential changes would be reflected also by neurophysiological measures and in QoL.
Discussion: Investigators hope to provide additional treatment tools for RRMS subjects, with a medium-long term efficacy and an extensive effect. This exploratory pilot study will help to set the rationale for future studies, providing preliminary data useful for selecting the best primary outcome and for calculating a better sample size.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
Browse Multiple Sclerosis studies →University of Milano Bicocca is the lead sponsor of 124 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 min/day of computerised cognitive training (CCT) + 20 min/day of real anodal transcranial direct current stimulation (tDCS). In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.
Device: Real tDCS + CCT
40 min/day of CCT + 20 min/day of apparent (sham) tDCS. In the first 20 min of the 40 min-intervention, tDCS and CCT will be provided simultaneously.
Device: Sham tDCS + CCT
40 min/day of computerised cognitive training (CCT) + 20 min/day of real anodal transcranial direct current stimulation (tDCS). In the first 20 min of the 40 min-intervention, real anodal tDCS and CCT will be provided simultaneously.
40 min/day of computerised cognitive training (CCT) + 20 min/day of apparent (sham) tDCS. In the first 20 min of the 40 min-intervention, sham tDCS and CCT will be provided simultaneously.
Change in Symbol Digit Modalities Test (SDMT)
Change in target cognitive test assessing information processing (i.e., SDMT)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Paced Auditory Serial Addition Test (PASAT)
Change in target cognitive test assessing information processing (i.e., PASAT)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Wisconsin Card Sorting Test (WCST)
Change in target cognitive test assessing frontal executive functions (i.e., WCST)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Stroop test
Change in target cognitive test assessing frontal executive functions (i.e., Stroop test)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Change in Digit Spans
Change in target cognitive tests assessing information processing and frontal executive functions (i.e., digit spans)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Number of sessions done by esch participants (Feasibility)
Overall compliance of the protocol, assessed by number of sessions done by esch participants (Feasibility)
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Number tDCS-related of discomfort or side effects experienced by each participants (Safety)
Any tDCS-related discomfort or side effect after each daily session
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)
Changes in single subtest of the BRBN-T
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Beck Depression Inventory (BDI)
21-question multiple-choice self-report inventory, higher score means worse depressive score.
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Expanded Disability Status Scale (EDSS) measurements
10 points scale, higher score means worse disease progression.
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Functional Composite (MFSC)
Three component parts, higher scores means worse functional symptoms.
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Modified Fatigue Impact Scale (MFIS)
three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. higher scores indicate a greater impact of fatigue
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in Multiple Sclerosis Quality of Life (MSQOL-54)
Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline
Comparison of alpha oscillation power from resting state EEG recordings on the first and last day of protocol. EEG data also recorded at 3- and 6-month follow up visits. Each of the four EEG recordings will serve to analyze alpha frequency activity for derivation of EEG biomarkers in this observational pilot study.
Time frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Plan to share: No
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This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Milano Bicocca