NCT04261556

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DEVICE	Real 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.
DEVICE	Sham tDCS + CCT	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.

Timeline

• Start date: 2019-11-21
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-02-10
• Last updated: 2024-01-03

Locations

1 site across 1 country: Italy