Clinical trial NCT04261556: tDCS to Enhance Cognitive Training in Multiple Sclerosis
Official title: Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple sclerosis
Relapsing remitting multiple sclerosis
Cognitive training
Cognitive rehabilitation
Cognitive remediation
Neuromodulation
Transcranial direct current stimulation
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in Symbol Digit Modalities Test (SDMT)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Change in Paced Auditory Serial Addition Test (PASAT)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Change in Wisconsin Card Sorting Test (WCST)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Change in Stroop test
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Change in Digit Spans
timeFrame: 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:
measure: Number of sessions done by esch participants (Feasibility)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
measure: Number tDCS-related of discomfort or side effects experienced by each participants (Safety)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1)
measure: Changes in Brief Repeatable Battery of Neuropsychological Tests (BRBN-T)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in Beck Depression Inventory (BDI)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in Expanded Disability Status Scale (EDSS) measurements
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in Multiple Sclerosis Functional Composite (MFSC)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in Modified Fatigue Impact Scale (MFIS)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in Multiple Sclerosis Quality of Life (MSQOL-54)
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
measure: Changes in alpha oscillations measured with Electroencephalogram (EEG) Resting State From Baseline
timeFrame: Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6)
Other outcomes:
Locations:
city: Monza
country: Italy
facility: University of Milano-Bicocca
Study officials:
References: