tDCS to Enhance Cognitive Training in Multiple Sclerosis
NCT04261556, Not applicable, Withdrawn, University of Milano Bicocca
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | tDCS to Enhance Cognitive Training in Multiple Sclerosis | ClinicalTrials.gov |
| NCT number | NCT04261556 | ClinicalTrials.gov |
| Status | Withdrawn | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 0 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Milano Bicocca | ClinicalTrials.gov |
| Conditions | Multiple Sclerosis, Relapsing-Remitting | ClinicalTrials.gov |
| Interventions | Real tDCS + CCT, Sham tDCS + CCT | ClinicalTrials.gov |
| First posted | 2020-02-10 | ClinicalTrials.gov |
| Last updated | 2024-01-03 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Symbol Digit Modalities Test (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 target cognitive test assessing information processing (i.e., SDMT) | ClinicalTrials.gov |
| Primary | Change in Paced Auditory Serial Addition Test (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 target cognitive test assessing information processing (i.e., PASAT) | ClinicalTrials.gov |
| Primary | Change in Wisconsin Card Sorting Test (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 target cognitive test assessing frontal executive functions (i.e., WCST) | ClinicalTrials.gov |
| Primary | Change in 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 target cognitive test assessing frontal executive functions (i.e., Stroop test) | ClinicalTrials.gov |
| Primary | Change in 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) | Change in target cognitive tests assessing information processing and frontal executive functions (i.e., digit spans) | ClinicalTrials.gov |
| Secondary | Number of sessions done by esch participants (Feasibility) | Day 0 (baseline, T0), Week 2 (end of treatment, T1) | Overall compliance of the protocol, assessed by number of sessions done by esch participants (Feasibility) | ClinicalTrials.gov |
| Secondary | Number tDCS-related of discomfort or side effects experienced by each participants (Safety) | Day 0 (baseline, T0), Week 2 (end of treatment, T1) | Any tDCS-related discomfort or side effect after each daily session | ClinicalTrials.gov |
| Secondary | Changes in Brief Repeatable Battery of Neuropsychological Tests (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 single subtest of the BRBN-T | ClinicalTrials.gov |
| Secondary | Changes in Beck Depression Inventory (BDI) | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | 21-question multiple-choice self-report inventory, higher score means worse depressive score. | ClinicalTrials.gov |
| Secondary | Changes in Expanded Disability Status Scale (EDSS) measurements | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | 10 points scale, higher score means worse disease progression. | ClinicalTrials.gov |
| Secondary | Changes in Multiple Sclerosis Functional Composite (MFSC) | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | Three component parts, higher scores means worse functional symptoms. | ClinicalTrials.gov |
| Secondary | Changes in Modified Fatigue Impact Scale (MFIS) | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. higher scores indicate a greater impact of fatigue | ClinicalTrials.gov |
| Secondary | Changes in Multiple Sclerosis Quality of Life (MSQOL-54) | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. | ClinicalTrials.gov |
| Secondary | Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline | Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Card Sorting Test (Berg) | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Paced Visual Serial Addition Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)