tDCS to Enhance Cognitive Training in Multiple Sclerosis

NCT ID: NCT04261556

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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, tDCS and CCT will be provided simultaneously.

Group Type: EXPERIMENTAL

Real tDCS + CCT

Intervention Type: 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.

Sham tDCS + CCT

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.

Group Type: SHAM_COMPARATOR

Sham tDCS + CCT

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Milano-Bicocca

Monza, , Italy

Countries

Italy

Other Identifiers

REHACOG-MS

Identifier Type: -

Identifier Source: org_study_id