The Neural Mechanisms of a Contralesionally-Driven Brain-Computer Interface for Motor Rehabilitation of Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Fugl-Meyer (Upper Extremity) Assessment Score
研究概览
简要总结
The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device. This study will also show whether passive movement of the affected hand as a result of brain-based control can cause rehabilitation from the effects of a stroke. Additionally, this study will show how rehabilitation with a brain-controlled device may affect the function and organization of the brain.
Stroke is the most common neurological disorder in the US with 795,000 strokes per year (Lloyd-Jones et al. 2009). Of survivors, 15-30% are permanently disabled and 20% require institutional care (Mackay et al. 2004; Lloyd-Jones et al. 2009). In survivors over age 65, 50% had hemiparesis, 30% were unable to walk without assistance, and 26% received institutional care six months post stroke (Lloyd-Jones et al. 2009). These deficits are significant, as recovery is completed after three months (Duncan et al. 1992; Jorgensen et al. 1995). This large patient population with decreased quality of life fuels the need to develop novel methods for improving functional rehabilitation. We propose that signals from the unaffected hemisphere can be used to develop a novel Brain-Computer interface (BCI) system that can facilitate functional improvement or recovery. This can be accomplished by using signals recorded from the brain as a control signal for a robotic hand orthotic to improve motor function, or by strengthening functional pathways through neural plasticity. Neural activity from the unaffected hemisphere to the affected hemiparetic limb would provide a BCI control in stroke survivors lesions that prevent perilesional mechanisms of motor recovery. The development of BCI systems for functional recovery in the affected limb in stroke survivors will be significant because they will provide a path for improving quality of life for chronic stroke survivors who would otherwise have permanent loss of function. Initially, the study will serve to determine the feasibility of using EEG signals from the non-lesioned hemisphere to control a robotic hand orthotic. The study will then determine if a brain-computer interface system can be used to impact rehabilitation, and how it may impact brain function. The system consists of a research approved EEG headset, the robotic hand orthotic, and a commercial tablet. The orthotic will be made, configured, and maintained by Neurolutions. Each participant will complete as many training sessions as the participant requires, during which a visual cue will be shown to the participant to vividly imagine moving their impaired upper extremity to control the opening and closing of the orthotic. Participants may also be asked to complete brain scans using magnetic resonance imaging (MRI).
详细描述
The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device. Additionally, this study will show whether passive movement of the affected hand as a result of brain-based control can cause rehabilitation from the effects of a stroke.
Stroke is the most common neurological disorder in the U.S. with 795,000 strokes per year (Lloyd-Jones et al. 2009). Of survivors, 77% experience weakness of loss of motor function in the upper limb (Lawrence et al, 2001). Motor recovery in post-acute stroke patients is complicated by an apparent plateau in the ability to achieve recovery beyond 3 months after stroke (Duncan et al. 1992; Jorgensen et al. 1995; Lloyd-Jones et al. 2009). The large patient population with decreased quality of life and requiring significant medical resource fuels the urgent need to develop novel methods for improving functional rehabilitation in chronic stroke survivors. We propose that cortical signals from the unaffected hemisphere of chronic stroke survivors can be used to control Brain-Computer Interface (BCI) system to facilitate functional recovery. The development of such rehabilitative BCI systems is significant because it provides a path to functional recovery currently unavailable to many chronic stroke patients.
Subject Selection:
Participants will be recruited from patient populations of collaborators and colleagues of the principal investigator, as well as from previous research studies of the principal investigator and colleagues. Participants from previous research studies will also be recruited. Colleagues will provide study information to interested candidates, and candidates will contact the research team if they will to be screened by study staff. Patients will be asked a series of screening questions to determine their eligibility for the study.
Study Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic stroke survivors at least 6 months post-stroke with moderate functional impairment of the right or left upper extremity as evidenced by motor function screening assessments
- •If receiving Botox injections in the upper extremity for spasticity management, device use must be initiated within 15 days of a Botox injection
排除标准
- •Cognitive impairment as indicated by a Short-Blessed Test score of 8 or more
- •Joint contractures in the affected wrist or digits
- •Receptive aphasia or inability to follow written instructions as indicated by a score of 6 or less on the Mississippi Aphasia Screening Test
- •High spasticity as indicated by a Modified Ashworth Scale of elbow flexion of 3 or greater
- •Unilateral visual inattention (i.e. "neglect") as determined by unilaterally omitting 3 or more targets on the Mesulam Cancellation Test
- •Patients contraindicated for MRI imaging due to safety concerns will be excluded from Group 1, but will have the option to be assigned to Group 2 should they meet other Inclusion and Exclusion criteria.
- •Inability to produce EEG signals sufficient for device control following EEG screening
研究组 & 干预措施
Range of Motion Therapy
Active and Passive Range-of-Motion (AROM, PROM) therapy strategies are commonly prescribed by physical therapists for at-home post-stroke motor deficit rehabilitation that can be performed independently. Patients practice movement with joints and limbs affected by the stroke, either by using the unaffected limb (or the assistance of a caretaker) to stretch the affected limb (PROM) or by actively moving the affected limb (AROM). Patients are asked to perform this therapy one hour per day, 5 days per week, for 12 weeks.
干预措施: Range of Motion Therapy (Other)
BCI Rehabilitation
Patients trained on use of BCI-controlled orthotic device are given a device for home use. Patients are asked to use the device an hour per day, 5 days per week, for 12 weeks. During device use, patients are instructed via pre-programmed instructions on a tablet paired with the device to either rest or vividly imagine moving their affected hand. The device receives signals from a scalp electrodes within a headset the patient dons prior to use. The device interprets these signals and closes the patient's hand during a successful rest trial, and opens the patient's hand during a successful move trial.
干预措施: BCI Rehabilitation (Device)
结局指标
主要结局
Change in Fugl-Meyer (Upper Extremity) Assessment Score
时间窗: 24 weeks from baseline
The primary outcome for determining motor function improvement is the change over time in the upper extremity portion of the Fugl-Meyer Assessment (FMA). The difference between FMA scores pre- and post-BCI rehab, subtracted by the change in FMA during range-of-motion therapy, will be used to quantify change in motor function.
次要结局
- Change in Corticospinal Tract Integrity(24 weeks from baseline)
- Change in Interhemispheric Somatomotor Connectivity(24 weeks from baseline)
- Change in Motricity Index(24 weeks from baseline)
- Change in Grasp Strength(24 weeks from baseline)
- Change in Arm Motor Ability Test Score(24 weeks from baseline)