tDCS to Enhance Cognitive Training in Multiple Sclerosis

NCT04261556 | Withdrawn DMC

• 1 other identifier: REHACOG-MS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple sclerosis; Relapsing remitting multiple sclerosis; Cognitive training; Cognitive rehabilitation; Cognitive remediation; Neuromodulation; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (5)

• Change in Symbol Digit Modalities Test (SDMT)

  Change in target cognitive test assessing information processing (i.e., 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 Paced Auditory Serial Addition Test (PASAT)

  Change in target cognitive test assessing information processing (i.e., 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 Wisconsin Card Sorting Test (WCST)

  Change in target cognitive test assessing frontal executive functions (i.e., 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 Stroop test

  Change in target cognitive test assessing frontal executive functions (i.e., 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 Digit Spans

  Change in target cognitive tests assessing information processing and frontal executive functions (i.e., 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)

Secondary Outcomes (9)

• Number of sessions done by esch participants (Feasibility)

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

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

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

• 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)

• 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)

Study Arms (2)

Real tDCS + CCT

EXPERIMENTAL

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.

Device: Real tDCS + CCT

Sham tDCS + CCT

SHAM COMPARATOR

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.

Device: Sham tDCS + CCT

Interventions

Real tDCS + CCT 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.

Real tDCS + CCT

Sham tDCS + CCT 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.

Sham tDCS + CCT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

University of Milano-Bicocca

Monza, 20900, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: February 10, 2020
• Study Start: November 21, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)