tDCS to Enhance Cognitive Training in Multiple Sclerosis (REHACOG-MS)

December 29, 2023 updated by: University of Milano Bicocca

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20900
        • University of Milano-Bicocca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symbol Digit Modalities Test (SDMT)
Time Frame: 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 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)
Time Frame: 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 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)
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sessions done by esch participants (Feasibility)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Overall compliance of the protocol, assessed by 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)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Any tDCS-related discomfort or side effect after each daily session
Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)
Time Frame: 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 single subtest of the 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)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
21-question multiple-choice self-report inventory, higher score means worse depressive score.
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
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
10 points scale, higher score means worse disease progression.
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 Multiple Sclerosis Functional Composite (MFSC)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Three component parts, higher scores means worse functional symptoms.
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)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. higher scores indicate a greater impact of fatigue
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 Multiple Sclerosis Quality of Life (MSQOL-54)
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores.
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 alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline
Time Frame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Comparison of alpha oscillation power from resting state EEG recordings on the first and last day of protocol. EEG data also recorded at 3- and 6-month follow up visits. Each of the four EEG recordings will serve to analyze alpha frequency activity for derivation of EEG biomarkers in this observational pilot study.
Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2019

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 4, 2019

First Submitted That Met QC Criteria

February 6, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REHACOG-MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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