Transcranial Direct Current Stimulation for Fatigue, Mood, and Cognition in Multiple Sclerosis: A Randomized, Double-Blind, Sham-Controlled, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Modified Fatigue Impact Scale (MFIS) - Total Score
研究概览
简要总结
Multiple sclerosis (MS) is a chronic, inflammatory and disabling disease of the Cnetral Nervous System characterized by relapsing and / or progressive somatosensory, motor and vestibular clinical manifestations. Moreover, fatigue, depression, anxiety, and cognitive impairment are also present in most MS patients. These symptoms substantially impact quality of life and often show limited response to conventional pharmacological treatment.
Transcranial direct current stimulation (tDCS) is a non-invasive technique that applies a weak direct current to the scalp via surface electrodes, modulating cortical excitability in a polarity-dependent manner.
The objective of this study is to evaluate the efficacy and safety of tDCS for fatigue, depression, anxiety, and cognitive performance in patients with relapsing or progressive MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years at the time of enrollment
- •Clinical diagnosis of Relapsing Multiple Sclerosis (RMS) or Progressive Multiple Sclerosis (PMS), with or without active progression, established per the 2014 McDonald diagnostic criteria
- •Expanded Disability Status Scale (EDSS) score of 0-3 at the time of screening
- •Time since initial MS diagnosis of at least 6 months
- •Active fatigue symptoms reported by the participant for at least the 6 months prior to enrollment
排除标准
- •History of neuropsychiatric illness (including major depression, bipolar disorder, schizophrenia, or any anxiety disorder) prior to the onset of multiple sclerosis
- •Diagnosis of neuromyelitis optica spectrum disorder (Devic's disease)
- •Presence of any other central nervous system disease
- •Disease duration greater than 10 years combined with an EDSS score of ≤ 2
- •Visual impairment secondary to optic neuritis, internuclear ophthalmoplegia (oculomotor disorder), or any other uncorrected visual impairment that would affect task performance on cognitive assessments
- •Current pharmacological treatment for fatigue or depression
- •Current neuropsychiatric pharmacological treatment, including any antidepressant, anxiolytic, neuroleptic, or anticonvulsant medication
- •Clinical relapse requiring corticosteroid treatment in the 3 months prior to enrollment
- •Severe upper-limb motor deficit that would prevent task performance on neuropsychological assessments
结局指标
主要结局
Modified Fatigue Impact Scale (MFIS) - Total Score
时间窗: Assessed at baseline (Day 0), immediately following the first 5-day stimulation block (Day 5), and immediately following the second 5-day stimulation block (Day 26 after washout)
The MFIS is a 21-item multidimensional self-report scale assessing the impact of fatigue on physical (9 items), cognitive (10 items), and psychosocial (2 items) functioning over the past 4 weeks. Each item is scored 0-4; total score ranges from 0 to 84. Higher scores indicate greater fatigue impact. The primary comparison is post-active-tDCS total score versus post-sham total score.
Modified Fatigue Impact Scale (MFIS) - Physical Subscale
时间窗: Baseline, Day 5, Day 26
Physical subscale of the MFIS (9 items; range 0-36). Assesses impact of fatigue on physical functioning. Compared between active tDCS and sham conditions.
Modified Fatigue Impact Scale (MFIS) - Cognitive Subscale
时间窗: Baseline, Day 5, Day 26
Cognitive subscale of the MFIS (10 items; range 0-40). Assesses impact of fatigue on cognitive functioning. Compared between active tDCS and sham conditions.
Modified Fatigue Impact Scale (MFIS) - Psychosocial Subscale
时间窗: Baseline, Day 5, Day 26
Psychosocial subscale of the MFIS (2 items; range 0-8). Assesses impact of fatigue on psychosocial functioning. Compared between active tDCS and sham conditions.
次要结局
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale(Baseline, Day 5, Day 26)
- Hospital Anxiety and Depression Scale (HADS) - Depression Subscale(Baseline, Day 5, Day 26)
- Visual Analog Scale (VAS) - Fatigue(Baseline, Day 5, Day 26)
- Visual Analog Scale (VAS) - Depression(Baseline, Day 5, Day 26)
- Symbol Digit Modalities Test (SDMT)(Baseline, Day 5, Day 26)
- California Verbal Learning Test-II (CVLT-II)(Baseline, Day 5, Day 26)
- Brief Visuospatial Memory Test-Revised (BVMT-R)(Baseline, Day 5, Day 26)
研究者
Asdrubal Rene Huerta Gallango
Principal Invetigator
Universidad de Almeria