Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Fugl-Meyer upper extremity assessment of sensorimotor function
研究概览
简要总结
The goal of the present clinical trial is to explore whether an innovative technology-based approach can help individuals who have had a stroke and can no longer move their hands with ease. Our approach consists of a combination of two technologies: Transcranial Magnetic Stimulation (TMS) and a Brain-Computer Interface (BCI). The former entails the application of magnetic fields over the head to stimulate the brain preparing it for a better ability to produce movement. The latter consists of measuring brain activity to personalize a type of computer-based training that is designed to increase communication between the brain and the muscles.
详细描述
Aims of the study:
- to provide preliminary evidence of the effect of rTMS (repetitive Transcranial Magnetic Stimulation) on brain-computer interface (BCI)-mediated plasticity on individuals with hemiparesis after stroke
- Measure adherence and withdrawal rates of the present protocol for informing a future large-scale randomized controlled trial
The active stimulation (rTMS) consists of an intermittent theta burst (iTBS) protocol whereas the placebo condition encompasses rTMS stimulation delivered with a Sham coil (Sham).
Procedures:
The study will entail 25 sessions. The study is composed of six different types of sessions in a crossover design:
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a subcortical stroke at least 6 months before the initiation of the trial and confirmed with magnetic resonance imaging (MRI) or computed tomography
- •Present moderate to severe hemiparesis in an upper limb
- •Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training
- •Age from 20 to 80 years old
- •Clear consciousness and stable vital signs
- •Eligible for MRI, EEG, BCI and TMS methods
排除标准
- •Drug abuse or recent changes in medications that may alter the central nervous system when the measurements begin or during the measurements (e.g., benzodiazepines, serotoninergic and dopaminergic agents)
- •History of seizure
- •Bone, joint and muscle diseases
- •Peripheral neuropathy or other neurological or psychiatric diseases (including, tinnitus, migraine, or mood disorders with the exception of minimal, mild, and moderate depression, reflected as a Beck depression scale score lower than 29).
- •Strong cognitive deficits (including speech, attention, hearing, vision, sensation or intelligence deficits) reflected as a Montreal Cognitive Assessment (MoCA) score lower or equal to 24
- •Lesions in the upper extremities
- •Bone, joint and muscle diseases
- •Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
- •Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
- •Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia
- •Participation in other interventional trials using BCI or rTMS within less than 6 months ago
- •Participation in another interventional clinical trial
- •Suspected lack of compliance
- •Pregnant or nursing women
结局指标
主要结局
Fugl-Meyer upper extremity assessment of sensorimotor function
时间窗: Measured one time at day, at the days: 2, 13, 14, and 25.
Quantitative evaluation of motor, balance, sensation and joint functions. The sums of values recorded before and after the stimulation periods will be fed into an unpaired sample t-test to evaluate carryover effects whereas the differences observed between recordings before and after the stimulation will be fed into an unpaired sample t-test for the evaluation of initial evidence of the effect of rTMS.
Motor-evoked potential (MEP) parameters
时间窗: Measured two times per day, at the days: 3-12 and 15-24. The first measurement is performed immediately before the rTMS-BCI intervention and the second immediately after the rTMS-BCI intervention.
An MEP is the electromyography response to a single TMS pulse delivered over the motor cortex, over the representation of multiple muscles. MEP changes will be evaluated with a mixed effects model. mixed-effects model. The model will consider the Patient, Period, Treatment (stimulation type) and Session number. The Period\*Treatment interaction will be verified to detect carry-over effects. The investigators expect to observe a main effect of Treatment and Session number.
Event-related desynchronization (ERD)
时间窗: Measured one time per day, at the days: 2, 13, 14, and 25.
Electroencephalography (EEG) will be recorded during a cued motor task. This data will be used to calculate event-related de-synchronization, defined as the difference in signal power in the miu (8-12 Hz) and beta bands (13-30 Hz) between a baseline period prior to the cue and a post-cue period. Changes in ERD will be evaluated with permutation-based statistics.
次要结局
- Brain-Computer Interface accuracy(Measured one time per day, at days 3-12 and days 15-24.)
- Task-related functional Magnetic Resonance Imaging (t-fMRI)(Measured one time per day, at the days 2, 13, 14, and 25.)
- Voxel-based morphometry(Measured one time per day, at the days 2, 13, 14, and 25.)
- Jebsen-Taylor Hand Function Test(Measured one time per day, at the days 2, 13, 14, and 25.)
- Resting-state functional Magnetic Resonance Imaging (rs-fMRI)(Measured one time per day, at the days 2, 13, 14, and 25.)
- Diffusion-based tractography(Measured one time per day, at the days 2, 13, 14, and 25.)
- Movement-related cortical potential amplitude(Measured one time per day, at the days 2, 13, 14, and 25.)
- Brain-derived neurotrophic factor (BDNF) in serum(Measured twice per day, at the days 3, 12, 15 and 24. The first measure occurs before the intervention and the second measure after the intervention.)