tDCS to Enhance Cognitive Training in Multiple Sclerosis

Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study

WithdrawnNot a drug-phase studyRelapsing MSNCT04261556

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Due to organizing difficulties after COVID-19 pandemic

What was tested

Treatment tested

  • Real tDCS + CCT

Placebo

  • Sham tDCS + CCT

What it measured

Main measures

  • 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)

    Thinking and memory

  • 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)

    Thinking and memory

  • 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)

    Thinking and memory

  • 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)

    Thinking and memory

  • 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)

    Thinking and memory

Other measures (9)

  • Number of sessions done by esch participants (Feasibility)

    Day 0 (baseline, T0), Week 2 (end of treatment, T1)

    Feasibility

  • Number tDCS-related of discomfort or side effects experienced by each participants (Safety)

    Day 0 (baseline, T0), Week 2 (end of treatment, T1)

    Safety

  • 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 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)

    Mood and sleep

  • 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)

    Disability progression

  • 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)

  • 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)

    Thinking and memoryFatigue

  • 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)

    Quality of life (reported by participants)

  • 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)

    Blood or spinal fluid markersNerve conduction tests

Who could take part

Relapsing MS · 18 to 65 · EDSS 0 to 5.5

Show the full criteria

Inclusion criteria

* Subjects with clinically definite diagnosis of relapsing remitting MS (RRMS); * Male or female subjects, 18 to 65 years old; * Expanded Disability Status Scale (EDSS) score ranging from 0 to 5.5 (included); * Predominant deficits in either attention/information processing; * Fluent Italian speakers; * Normal or corrected-to-normal vision; * Ability to understand the purpose and risk of the study and provide signed informed consent.

Exclusion criteria

* MS patients in different phase of the disease (as primary/secondary progressive MS; benign MS) or Clinical Isolated Syndrome (CIS) patients; * Exclusive cognitive impairment in different domains (e.g., memory); * CT/neuromodulation program ongoing or in the preceding 6 months; * Clinical exacerbations, neuroradiological activity of the disease, modification of EDSS score and disease modifying treatments/steroids during the last 3 months preceding study enrolment; * Significant medical disorders or other major systemic, psychiatric, neurological disorders or alcohol/substance abuse that could interfere with cognitive functioning; * Antidepressant/psychoactive drugs in the past 3 months; * Contraindications to tDCS (intracranial metallic plates, implanted devices, skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, pregnancy, etc).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Nov 2019

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2024

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