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Due to organizing difficulties after COVID-19 pandemic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tDCS + CCT | Experimental | 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. |
|
| Sham tDCS + CCT | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real tDCS + CCT | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symbol Digit Modalities Test (SDMT) | Change in target cognitive test assessing information processing (i.e., SDMT) | 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) | 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) | 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) | 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) | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sessions done by esch participants (Feasibility) | Overall compliance of the protocol, assessed by number of sessions done by esch participants (Feasibility) | Day 0 (baseline, T0), Week 2 (end of treatment, T1) |
| Number tDCS-related of discomfort or side effects experienced by each participants (Safety) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Milano-Bicocca | Monza | 20900 | Italy |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Sham tDCS + CCT | Device | 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. |
|
Any tDCS-related discomfort or side effect after each daily session |
| 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 | 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. | 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. | 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. | 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 | 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. | 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. | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |