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

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.

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).