High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Cortical excitability assessed via TMS
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is a nervous system disease that causes muscle weakness and rapidly progresses to the loss of mobility and functionality. Studies suggest that High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a technique for modulating motor cortical hyperexcitability. However, evidence on the use of HD-tDCS as a neuromodulator of the diaphragmatic motor cortex in people with ALS is inconclusive.
详细描述
A multicenter, randomized controlled clinical trial will be conducted. Participants will be randomized into two groups: the HD-tDCS group (gTDCS) and the sham tDCS group (gSham). The intervention protocol will assess the effects of HD-tDCS on respiratory parameters and ALS progression. The study will include individuals of both sexes, aged 18 to 80 years, with a clinical diagnosis of ALS, evaluated before, during, and after the home-based HD-tDCS protocol. The electrodes will be positioned in a circular arrangement over the primary diaphragmatic motor cortex, applying a continuous anodal current intensity. For placebo comparison, only an initial 30-second ramp stimulus will be applied, followed by a minimal current, resulting in no significant intervention. The intervention will be conducted at the participant's home, once daily, five days per week, for two weeks. Patients will undergo evaluations of lung function, cough peak flow, respiratory muscle strength, nasal respiratory pressures, functional capacity, muscle fatigue, cognitive function, as well as surface electromyography of respiratory muscles during active and assisted breathing curves using transcranial magnetic stimulation (TMS), cortical excitability, central tissue oxygenation, respiratory muscle tissue oxygenation, functionality and disease progression, motor control and muscle performance, fatigue and dyspnea, sleep analysis, quality of life, and adverse effects.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes; diagnosis of ALS according to the revised El Escorial criteria;
- •Age between 18 and 80 years;
- •Forced Vital Capacity greater than 50% of predicted;
- •Sniff nasal inspiratory pressure greater than 40 cmH2O;
- •A telephone number to contact the care team and who signed the study consent form.
排除标准
- •Subjects who are unable to understand or perform any of the study procedures;
- •Subjects who do not agree to participate or voluntarily request withdrawal from the study at any time;
- •Subjects with cardiac, respiratory, or musculoskeletal comorbidities;
- •Subjects using invasive mechanical ventilation;
- •Subjects with a tracheostomy;
- •Subjects with a pacemaker;
- •Subjects with metallic brain implants or other electronic implants;
- •Subjects with a cochlear implant;
- •Subjects with epileptic activity or a history of epilepsy, or a family history of epilepsy;
- •Subjects with a history of stroke or tumor;
- •Subjects prone to severe hemodynamic fluctuations, acute infectious processes, and/or inflammatory conditions;
- •Pregnant women at the time of recruitment;
- •Subjects who are unable to complete the intervention protocol.
研究组 & 干预措施
HD-tDCS sham group
Patients randomly included in this group will receive 10 sessions of sham HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex. Only an initial 30-second ramp stimulus will be applied, followed by a non-effective current
干预措施: Simulated HD-tDCS (Device)
Active HD-tDCS Group
Patients randomly included in this group will receive 10 sessions of anodal HD-tDCS stimulation. The intervention will take place at the participant's home, with electrodes positioned in a circular arrangement-one central electrode and four peripheral electrodes-over the cortical representation zone of the left primary diaphragmatic motor cortex, with a continuous current applied
干预措施: Active HD-tDCS (Device)
结局指标
主要结局
Cortical excitability assessed via TMS
时间窗: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Cortical excitability assessed by means of Transcranial Magnetic Stimulation measuring motor evoked potentials, cortical inhibition and duration of the cortical silent period
Cortical tissue oxygenation
时间窗: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
Assessment of cortical tissue oxygenation using brain coupled near-infrared spectroscopy technique coupled to the brain to monitor cerebral oxygenation and regional cerebral oxygen saturation.
Electromyographic activity of specific respiratory muscles
时间窗: From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up)
This outcome will be assessed through Electromyography of the sternocleidomastoid, scalene, parasternal, hemidiaphragm and rectus abdominis muscles
次要结局
- Respiratory function assessed by spirometry(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Maximum Inspiratory and Expiratory Pressure(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Cough Peak Flow(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Respiratory muscle oxygenation via near-infrared spectroscopy(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Peripheral upper limb muscle activity assessed via electromyography(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Functionality and disease progression(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Fatigue Severity(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Dyspnea assessed via Modified Borg Scales(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Quality of sleep assessment(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Quality of life assessed using the Brief ALS-specific Quality of Life Questionnaire(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
- Subjective assessment of stimulation-related effects(From the date of randomization (1 week before the start of the intervention) up to 6 months (follow-up))
研究者
Guilherme Augusto de Freitas Fregonezi
Professor, PhD
Universidade Federal do Rio Grande do Norte