Innovative Protocol Targeting Cognitive Dysfunction in Multiple Sclerosis: tDCS to Enhance Cognitive Training in a Randomized, Double-blind, Controlled, Exploratory Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Paced Auditory Serial Addition Test (PASAT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Real tDCS + CCT (Device)
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.
干预措施: Sham tDCS + CCT (Device)
结局指标
主要结局
Change in Paced Auditory Serial Addition Test (PASAT)
时间窗: 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)
Change in Symbol Digit Modalities Test (SDMT)
时间窗: 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)
Change in Wisconsin Card Sorting Test (WCST)
时间窗: 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)
Change in Stroop test
时间窗: 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)
Change in Digit Spans
时间窗: 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)
次要结局
- 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))
- Changes in Modified Fatigue Impact Scale (MFIS)(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)(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(Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6))
- Number of sessions done by esch participants (Feasibility)(Day 0 (baseline, T0), Week 2 (end of treatment, T1))
- Changes in Multiple Sclerosis Functional Composite (MFSC)(Day 0 (baseline, T0), Week 2 (end of treatment, T1), Follow-up at 3 months (FU3) and follow-up at 6 months (FU6))