Brain Monitoring, tDCS and Robotic Training in SCI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Motor Threshold
研究概览
简要总结
To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
详细描述
Current training interventions for rehabilitating patients with SCI are designed to provide the greatest possible restoration of function in the shortest possible time. One of the major deficits in our current approach to applying therapy is that we have little ability to predict which patients are most likely to respond to therapy or which muscle groups are most amenable to improvement. Transcranial magnetic stimulation (TMS) is a noninvasive method to excite or inhibit neurons in the brain or the spinal cord. Numerous studies have been using this technique to map connections from the motor cortex via the spinal cord to peripheral muscles; and as a therapeutic tool to promote useful plasticity.
The significance of the present study lies in the potential of intensive upper limb motor training with a novel robotic device, in conjunction with transcranial direct current stimulation (tDCS) over the contralateral motor cortex, may enhance neural recovery and upper limb function in patients with tetraplegia.
The robotic training devices represent the most sophisticated interactive rehabilitation systems available on the current market; they are additionally appealing for their ability to quantify various aspects of movement, and they appear to be particularly powerful way to promote functional recovery. Furthermore, robotic devices can be used in collection of quantitative data from the patients, which can be interpreted to analyze their rate of progress. Rehabilitation robots are capable of providing important components of motor skill learning and muscle training: individually prescribed intensity, repetition, and performance feedback. Furthermore, they are a novel and reliable method of assessing voluntary motor control. Our center has extensive experience in the use of rehabilitation robotics in the assessment and training of voluntary motor control in SCI patients, as well as other neurological disorders. From the investigator's previous experience using robotic therapy in SCI patients they can predict that some patients (approximately 10%) will show direct benefits from the interactive robot training.
The use of neuromodulatory techniques (TMS, tDCS) has been used for the last 2 decades in neurorehabilitation with the aim of enhance motor recovery when paired with activity dependent plasticity (training). In this proposal the investigator's will be using a new tDCS device, StarStim® - a wireless multichannel device that allows EEG recording as well as real or sham tDCS stimulation.
The purpose of this study is: To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Level of injury C5 to T1
- •Chronic SCI > 6 months
- •Tetraplegic with some degree of motor dysfunction in the upper limb
- •Motor Incomplete/Complete
- •Medically stable
排除标准
- •< 6 month after injury
- •History of head trauma and/or cognitive deficit
- •History of stroke, seizures or other intracranial disease
- •Medically unstable
- •Concomitant neurological disorder
- •Pre-existing medical conditions interfering with unrestricted movement of the hand/arm (e.g. osteoarthritis, injury to the joints)
- •Inability to provide informed consent
- •Contraindications for non-invasive brain stimulation (NIBS) techniques (TMS & tDCS)- see below.
- •Non-Invasive Brain Stimulation Contraindications
- •Surgically implanted foreign bodies such as a pacemaker, implanted medication pump, metal plate in the skull
- •Metal inside the skull (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
- •No skin condition
- •Any significant medical or psychiatric illness
- •History of epilepsy
研究组 & 干预措施
tDCS & EEG
20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients.
干预措施: Electroencephalography (EEG) (Diagnostic Test)
Sham tDCS
2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS.
干预措施: Upper extremity robot (Device)
Active tDCS
2 weeks (5x per week) of upper limb robotic training in conjunction with active tDCS.
干预措施: Upper extremity robot (Device)
结局指标
主要结局
Motor Threshold
时间窗: Change in motor threshold from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
The necessary stimulator output to evoke a response in the target muscle
Action Research Arm Test
时间窗: Baseline, immediately after intervention.
Assessment of upper extremity motor improvements
Amplitude of Response
时间窗: Change in amplitude from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
The size of the wave form (response) generated during motor threshold determination.
次要结局
- Transcranial magnetic stimulation mapping(Baseline, immediately after intervention, and 1 month follow up)
- Electroencephalography (EEG) Recording(Baseline, immediately after intervention, and 1 month follow up)
- Muscle Strength Evaluation(Baseline, immediately after intervention, and 1 month follow up)
- Upper Extremity Motor Score (UEMS)(Baseline, immediately after intervention)
- Spinal Cord Independence Measure (SCIM III)(Baseline, immediately after intervention)
- Visual Analogue Scale(Baseline, immediately after intervention)
- Quadriplegia Index of Function (QIF)(Baseline, immediately after intervention)
- Jebsen-Taylor Hand Function Test(Baseline, immediately after intervention)
- Motor Evoked Potential Facilitation(Baseline, immediately after intervention, and 1 month follow up)
研究者
Kathleen Friel
Lab Director, Clinical Laboratory for Early Brain Injury Recovery
Burke Medical Research Institute
