Rehabilitative Trial With Transcranial Direct Current Stimulation (tDCS) in Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Muscle Strength From Baseline
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.
详细描述
Amyotrophic Lateral Sclerosis (ALS) is a motor neuron disease, which is a group of neurological disorders that selectively affect motor neurons, the cells that control voluntary muscles of the body. The disorder causes muscle weakness and atrophy throughout the body due to the degeneration of the upper and lower motor neurons. Current drugs approved for ALS treatment only modestly slow disease progression.
Transcranial direct current stimulation (tDCS) is a non-invasive technique, which has been demonstrated to modulate cerebral excitability in several neurodegenerative disorders and modulate intracortical connectivity measures.
In this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with bilateral motor cortex anodal tDCS and spinal cathodal tDCS can improve symptoms in patients with amyotrophic lateral sclerosis and modulate intracortical connectivity, at short and long term.
Subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal bilateral motor cortex tDCS and cathodal spinal tDCS and the other receiving sham stimulation with identical parameters. After the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 2 months and 6 months after treatment. Furthermore, blood neurofilaments will be measured at each time point.
Clinical evaluation will include the ALSFRS-R, ALSAQ-40, CBI, EQ-5D-5L, muscle strength evaluated with the MRC scale.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of probable, laboratory-supported probable, or definite amyotrophic lateral sclerosis according to the El Escorial revised criteria
- •Disease duration ≤ 24 months
- •Disease progression in the past 3 months
- •Score ≥ 2 at the item "swallowing" of the ALS Functional Rating Scale Revised
- •Score ≥ 2 at the item "walking" of the ALS Functional Rating Scale Revised
- •Treatment with steady regimen of riluzole for a minimum of 1 month before study entry, and desiring its continuation
- •Able to give informed consent
- •Written informed consent
排除标准
- •Motor neuron diseases other than ALS
- •Severe head trauma in the past
- •History of seizures
- •History of ischemic stroke or hemorrhage
- •Pacemaker
- •Metal implants in the head/neck region
- •Severe comorbidity
- •Intake of illegal drugs
- •Pregnancy
结局指标
主要结局
Change in Muscle Strength From Baseline
时间窗: Baseline - 2 weeks - 2 months - 6 months
A megascore is obtained by summing scores of single muscles (shoulder abductors, elbow flexors and extensors, wrist flexors, thumb opponent, hip flexors, knee flexors and extensors, and ankle dorsiflexors and extensors on both sides) manually evaluated according to the Medical Research Council (MRC) scale, which ranges from 0 (no movement) to 5 (normal contraction). The score for each muscle is summed, with scores ranging from 100 (no impairment) to 0 (most severe impairment).
次要结局
- Change Intracortical Facilitation (ICF) From Baseline(Baseline - 2 weeks - 2 month - 6 months)
- Change in Short-interval Intracortical Inhibition (SICI) From Baseline(Baseline - 2 weeks - 2 months - 6 months)
- Change of Quality of Life From Baseline: EQ-VAS Scale(Baseline - 2 weeks - 2 months - 6 months)
- Change of Quality of Life From Baseline: ALSAQ-40 Scale(Baseline - 2 weeks - 2 months - 6 months)
- Change of Quality of Life From Baseline: EQ-5D-5L Scale(Baseline - 2 weeks - 2 months - 6 months)
- Change in the ALSFRS-R Score From Baseline(Baseline - 2 weeks - 2 months - 6 months)
- Change in Caregiver Burden (CBI)(Baseline - 2 weeks - 2 months - 6 months)
研究者
Barbara Borroni
Professor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia