Evaluation of the Efficacy of Transcranial Direct Current Stimulation in Reducing Fatigue and Improving Quality of Life in Patients With Multiple Sclerosis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fatigue Impact
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the application of three 2-week cycles of tDCS combined with motor therapy is more effective in reducing fatigue in adult patients with multiple sclerosis, compared to the application of two cycles of the same treatment. The main questions aim to answer:
- Is the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) more effective for the recovery of fatigue in adult patients with multiple sclerosis compared to the application of two cycles of the same treatment (control group)?
- Is tDCS combined with motor therapy effective in improving fatigue in adult patients with multiple sclerosis in both study arms, i.e., in the pre-post assessment of the experimental group and the pre-post assessment of the control group? Researchers will compare the application of three 2-week cycles of tDCS combined with motor therapy (experimental group) to the application of two cycles of the same treatment (control group) to see if the experimental group shows greater recovery of fatigue in adult patients with multiple sclerosis.
Participants will:
- Visit the clinic for two weeks to be evaluated (baseline measurement and first post-treatment assessment) and receive the first cycle of treatment from Monday to Friday.
- Have a washout period of one month between the first and the second cycle.
- Visit the clinic for two weeks to receive the second cycle of treatment and be evaluated (second post-treatment assessment).
- Only participants in the experimental group will have another washout period of one month and visit the clinic to receive a third cycle of treatment and to be evaluated (third post-treatment assessment).
- Only participants in the control group will visit the clinic one and a half months after completing their second cycle to be measured as a follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple sclerosis defined according to the McDonald criteria (2017 revised version).
- •Age between 18 and 75 years.
- •No relapse in the last 2 months.
- •Fatigue experienced in the last 6 months, according to the Fatigue Severity Scale (FSS > 4).
排除标准
- •Patients who have not had stable pharmacological treatment in the last month.
- •Patients with contraindications to the use of tDCS, such as: defibrillator, pacemaker, brain stimulator, implanted intracranial metals, skull fractures or fissures, damaged skin or recent scars, epilepsy, pregnancy.
- •Patients who are undergoing or need to undergo immunosuppressive treatment for MS with Ocrelizumab, Rituximab, Lemtrada, or Mavenclad one week before or during the application of tDCS.
- •Patients with cognitive difficulties that prevent them from understanding the applied scales.
- •Patients who experience adverse effects from tDCS treatment.
- •Inability to remain in the study and complete the third cycle and/or the V3 assessment.
研究组 & 干预措施
Three cycles of tDCS combined with motor tasks group
Three 2-week cycles. Each cycle includes tDCS combined with motor tasks. The initial session of the first cycle and the final sessions of the second and third cycles last 45 minutes, involving tDCS and motor tasks, and MFIS, MSQOL-54, and BBS assessments. Other sessions last 30 minutes, focusing on tDCS and motor tasks.
tDCS Parameters: Intensity: 2000 mA Application Time: 20 minutes with a 10-second ramp-up Electrode placement: Anode at C3, Cathode at FP2
干预措施: Three cycles of tDCS combined with motor tasks (Other)
Two cycles of tDCS combined with motor tasks group
Two 2-week tDCS cycles will be conducted. Each cycle includes tDCS combined with motor tasks. The initial session of the first cycle and the final sessions of the second cycle last 45 minutes, involving tDCS and motor tasks, and MFIS, MSQOL-54, and BBS assessments. Other sessions last 30 minutes, focusing on tDCS and motor tasks.
tDCS Parameters:
- Intensity: 2000 mA
- Time: 20 minutes with a 10-second ramp-up
- Electrode Placement: Anode at C3, Cathode at FP2
干预措施: Two cycles of tDCS combined with motor tasks (Other)
结局指标
主要结局
Fatigue Impact
时间窗: Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3).
Fatigue Impact Scale measures the impact of fatigue on daily functioning across three domains: cognitive, physical, and psychosocial. It consists of 40 items rated on a scale from 0 (no problem) to 4 (extreme problem). The total score ranges from 0 to 160, with higher scores indicating greater fatigue impact. Subscale scores are also calculated for each domain
次要结局
- Multiple Sclerosis Quality of Life assessment(Assessed at baseline (V0), after 2 weeks (V1), after 6 weeks (V2), and after 14 weeks (V3))
- Balance(Assessed at baseline (V0), post-first cycle (V1, after 2 weeks), post-second cycle (V2, after 6 weeks), and post-third cycle (V3, after 14 weeks)).)
研究者
Marina Castel Sánchez
Marina Castel Sánchez
European University of Madrid