tDCS to Enhance Cognitive Training in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— REHACOG-MS  

Official title:

Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04261556
• Other study ID #: REHACOG-MS
• Status: Withdrawn
• Phase: N/A
• Start date: November 21, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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 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.

Locations

Country	Name	City	State
Italy	University of Milano-Bicocca	Monza

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Number of sessions done by esch participants (Feasibility)	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)
Secondary	Number tDCS-related of discomfort or side effects experienced by each participants (Safety)	Any tDCS-related discomfort or side effect after each daily session	Day 0 (baseline, T0), Week 2 (end of treatment, T1)
Secondary	Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)	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)
Secondary	Changes in Beck Depression Inventory (BDI)	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)
Secondary	Changes in Expanded Disability Status Scale (EDSS) measurements	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)
Secondary	Changes in Multiple Sclerosis Functional Composite (MFSC)	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)
Secondary	Changes in Modified Fatigue Impact Scale (MFIS)	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)
Secondary	Changes in Multiple Sclerosis Quality of Life (MSQOL-54)	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)
Secondary	Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline	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)