Motor Planning, Execution, and Modulation in Healthy Individuals and Patients With Movement Disorders or Neuromuscular Diseases Using Traditional Physical Activity or Advanced Devices to Enhance Motor Learning and Sensorimotor Processing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG.
研究概览
简要总结
The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases.
This study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy.
The main questions it aims to answer are:
How do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery.
Participants will:
- Undergo various rehabilitation protocols including physical activity and advanced interventions.
- Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.
详细描述
Objectives
Primary Objectives Investigating Motor Gesture Control: Study the sensory-motor structures and their connectivity in healthy participants and patients with neurological, cardiovascular, or neuromuscular conditions. This includes analyzing responses to advanced interventions such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and the CAREN (Computer Assisted Rehabilitation Environment) system.
Understanding Central Control Mechanisms: Assess spatial and temporal changes in brain activity during motor training and recovery processes, leveraging advanced neuroimaging techniques (e.g., fMRI, dtMRI, NIRS).
Secondary Objectives Postural Disorder Prevention: Develop strategies to enhance postural stability and prevent related disorders, improving sports performance and the quality of life in patients with neurodegenerative conditions.
Integration of Imaging and Psychometric Data: Employ multimodal data to uncover brain function patterns and inform rehabilitation strategies, contributing to personalized recovery protocols and optimized training methods.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
In this study:
Investigator: Not masked; investigators will be aware of the intervention each participant receives to monitor and administer the assigned treatments.
Outcomes Assessor: Masked to the intervention each participant receives to ensure an unbiased evaluation of outcomes.
Participants: Not masked; participants are aware of the intervention they are receiving as it involves different types of therapies and exercises.
Data Analysts: Masked to participant group assignments during initial data analysis to prevent bias in interpreting results.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20.
排除标准
- •Severe medical and psychiatric disorders potentially affecting the training
结局指标
主要结局
Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG.
时间窗: Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).
Motor-related EEG activity will be recorded during the execution of standardized gestures. The primary outcome is the mean amplitude (in µV) of specific ERP components (e.g., N200, P300) over motor cortex electrodes. Data will be averaged across trials for each participant and reported as group means ± standard deviation. Differences between healthy participants and clinical groups will be assessed using appropriate statistical tests.
次要结局
- Respiratory Exchange Ratio (RER) During Submaximal Exercis(Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).)
- Change in Global Cognitive Function as Measured by MoCA Total Score(Baseline (T0), post-intervention (T1, 12 weeks after baseline), and follow-up (T2, 3 months post-intervention).)
研究者
Rocco Salvatore Calabrò
MED, PhD
IRCCS Centro Neurolesi Bonino Pulejo