Non-invasive Brain Stimulation and Exercise Intervention for Patients With Motor Neuron Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Amyotrophic Lateral Sclerosis Functional rating scale - revised version (ALSFRS-R)
研究概览
简要总结
Motor neuron disease (MND) is a progressive neurological disorder involving degeneration of motor neurons, leading to muscle weakness, speech and swallowing difficulties, and respiratory failure. This study aims to develop a novel treatment approach combining personalized repetitive transcranial magnetic stimulation (rTMS) with mixed reality (MR) exercise-based games (exergames) to slow disease progression and improve quality of life. In this randomised controlled trial study will compare three groups: (1) rTMS with MR exercise (personalized intervention), (2) rTMS with MR exercise (standard intervention), and (3) sham rTMS with MR exercise. Outcomes will be assessed at baseline, 3 months, and 6 months post intervention. The long-term goal is to implement this approach in clinical settings to enhance care for people with MND.
详细描述
After screening process, eligible participants will be invited to visit Chula Neuroscience Center for the baseline assessments which will take proximately 2 hours.
The baseline assessments will be as follow:
- Demographic information such as age, sex, body height, body weight, body mass index, date of diagnosis, type of MND, and current medications.
- Questionnaires including amyotrophic lateral sclerosis functional rating scale - revised version (ALSFRS-R), penn upper motor neuron score (PUMNS), patient health questionnaire (PHQ-9), and EuroQol 5-Dimension 5-level (EQ-5D-5L).
- Clinical assessments including hand grip test, pinch grip test, and hand function.
- Lung function tests such as forced vital capacity (FVC).
- Neurophysiological assessment by using transcranial magnetic stimulation (TMS)
- Electromyography (EMG) including compound muscle action potential (CMAP), motor unit number estimation (MScan fit-MUNE), and motor unit number index (MUNIX).
- Magnetic resonance imaging (MRI)
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 (Participant)
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
- •Participants aged between 18 and 80 years
- •Diagnosed with any type of motor neuron disease (MND)
- •Have mild to moderate severity, as assessed by the Sinaki-Mulder scale, with a severity level between 1 and 3
排除标准
- •History of other neurological disorders, such as stroke
- •Use of ventilatory support
- •Severe dementia
结局指标
主要结局
Amyotrophic Lateral Sclerosis Functional rating scale - revised version (ALSFRS-R)
时间窗: ALSFRS-R will be measured at three time points (baseline, 3-month, and 6-month post intervention).
The Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) is a 12-item questionnaire used to assess functional ability in people with ALS across four domains: bulbar, fine motor, gross motor, and respiratory function. Each item is scored from 0 (unable) to 4 (normal), with a total score ranging from 0 to 48. It can be self-reported or clinician-administered in person, by phone, or online. Lower scores indicate greater disability. The ALSFRS-R is used to monitor disease progression and guide clinical care.
Muscle evoke potential (MEP)
时间窗: MEP will be mesured at three time points (baseline, 3-month, and 6-month post intervention).
Participants will be stimulated at the primary motor cortex by transcranial magnetic stimulation to measure cortical excitability, which sends the motor outputs to Tibialis Anterior (TA) and Abductor Pollicis Brevis (APB) muscles. The MEP will be used to assess muscle activity in these muscles during the stimulation. The MEP will be measured in mV.
Motor unit number estimation (MScan fit-MUNE)
时间窗: MScan fit-MUNE will be mesured at three time points (baseline, 3-month, and 6-month post intervention).
For MScan fit-MUNE, CMAP is recorded at multiple stimulation intensities. The MScan fit-MUNE software then generates a curve representing the relationship between stimulation intensity and CMAP amplitude. A mathematical model is fitted to this curve to estimate the number of motor units contributing to the generation of the CMAP.
Motor unit number index (MUNIX)
时间窗: MUNIX will be measured at three time points (baseline, 3-month, and 6-month post intervention).
For MUNIX (Motor Unit Number Index), the procedure begins with recording the CMAP. Then, the participant is asked to gently contract the muscle. During this contraction, the interference pattern of muscle electrical activity is recorded. The MUNIX value is calculated by analyzing the ratio between the CMAP amplitude and the amplitude of the interference pattern. This provides an estimate of motor unit function.
Cortical silent period (CSP)
时间窗: Muscle evoke potential will be measured at three time points (baseline, 3-month, and 6-month post intervention).
Participants will be stimulated at the primary motor cortex by transcranial magnetic stimulation to measure cortical excitability, which sends the motor outputs to Tibialis Anterior (TA) and Abductor Pollicis Brevis (APB) muscles. The CSP will be used to assess muscle activity in these muscles during the stimulation. The CSP will be measured in ms.
次要结局
- Muscle mass(Muscle mass will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Body mass index (BMI)(BMI will be measured at three time point (baseline, 3-month, 6-month post intervention).)
- Hand grip test(Hand grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Pinch grip test(Pinch grip test will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Hand function(Hand function will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Penn upper motor neuron score (PUMNS)(PUMNS will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Patient health questionnaire (PHQ-9)(PHQ-9 will be measured at three time points (baseline, 3-month, and 6-month).)
- EuroQol 5-Dimension 5-level (EQ-5D-5L)(EQ-5D-5L will be measure at three time ponts (baseline, 3-month, and 6-months post intervention).)
- Forced vital capacity (FVC)(FVC will be measured at three time points (baseline, 3-month, and 6-month post intervention).)
- Magnetic resonance imaging (MRI)(Brain imaging using MRI will be measured at three time points (baseline, 3-month and 6-month post intervention).)
- Compound muscle action potential (CMAP)(CMAP will be meausred at three time points (baseline, 3-month, and 6-month post intervention).)