Novel Spatial-Motor Approaches to Improve Spatial Neglect and Walking Deficits Post-Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 6
- 主要终点
- Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]
研究概览
简要总结
The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.
详细描述
Spatial Neglect (SN) is defined as pathological asymmetric spatial behavior causing functional disability and occurs in greater than 50% of individuals with right hemisphere stroke. SN post-stroke is associated with increased fall risk, increased hospital length of stay, poorer rehabilitation outcomes, and severe long-term disability. Prism adaptation therapy (PAT) is an evidence-based treatment for SN after stroke, however, the effects of SN on gait are not well known. Neuromuscular electrical stimulation delivered via surface electrodes is a common therapeutic adjunct in stroke rehabilitation, including for SN and gait training. However, the additive therapeutic effects of combining electrical stimulation and PAT, as well as the effects of motor training on gait deficits associated with SN are poorly understood. Furthermore, although there is limited literature examining the effects of electrical stimulation on corticospinal tract output (CST), there is an inadequate understanding of the neural mechanisms of PAT and the combinatorial effects of PAT with electrical stimulation. To parse out the neural mechanisms of PAT and electrical stimulation on the visuospatial system, researchers will first examine the effects of PAT with or without electrical stimulation in neurologically unimpaired adults, researchers will then compare results to individuals with stroke with spatial neglect.
The primary objective is to study the effects of PAT on visuospatial behavior and motor cortical excitability in able-bodied individuals (young and older), and on spatial neglect, motor cortical neurophysiology, and walking function in individuals post-stroke.
The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols targeting SN deficits and gait dysfunction to reduce disability in stroke survivors. The rationale of this project is to explore and generate data regarding future novel combinatorial motor-spatial retraining approaches that will enhance the rehabilitation approach of SN and gait performance in individuals post-stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
Both experiments include a sham condition: Sham electrical stimulation consisting of electrode placement with the stimulator turned off.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young Adults Able Bodied (YAB) Individuals
- •18-30 years
- •Able-Bodied (healthy without any physical disability or neurological disorder)
- •Older Adults Able-Bodied Individuals (OAB)
- •45-90 years
- •Able-Bodied (healthy without any physical disability or neurological disorder)
- •Individuals with right hemisphere stroke (40-90 years)
- •>3 months following stroke.
- •Presence of Aiming SN
- •Ability to walk >10m with or without assistive devices.
- •Unilateral left-sided hemiparesis with gross arm strength of ≤ grade 4/5 on the Medical Research Council Scale
- •Ability to follow 3-stage commands and provide informed consent.
排除标准
- •Young Adults Able-Bodied (YAB) Individuals and Older Adults Able-Bodied Individuals (OAB)
- •History or evidence of orthopedic or physical disability
- •History or evidence of neurological pathology
- •Pregnancy (female)
- •Uncontrolled hypertension
- •Cardiac pacemaker or other implanted electronic system
- •Presence of skin conditions preventing the electrical stimulation setup
- •Impaired sensation in the left upper limb.
- •Bruises or cuts at the stimulation electrode placement site
- •Concurrent enrollment in rehabilitation or another investigational study.
- •History or evidence of orthopedic or physical disability interfering with study procedures
- •History or evidence of neurological pathology or disorder
- •Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
- •Contraindications to TMS, such as metal implants, medications that can increase cortical excitability, and unexplained dizziness in the past 6 months
- •Individuals with right hemisphere stroke (40-90 years)
- •History or brainstem strokes
- •Cerebellar disorders
- •Impaired sensation in the left upper limb.
- •History of other neurological disorders
- •Uncontrolled hypertension
- •Cardiac pacemaker or other implanted electronic system
- •Pregnancy (female)
- •Presence of skin condition
- •Bruises at the electrode placement site
- •Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) or other medical conditions that can interfere with study procedures
- •Contraindications to TMS, such as metal implants in the brain, medications that will increase cortical excitability, etc.
研究组 & 干预措施
Young Able-Bodied individuals
18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
干预措施: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) (Device)
Young Able-Bodied individuals
18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
干预措施: Prism adaptation therapy (PAT) + Sham Stimulator (Device)
Old Able-Bodied individuals
45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
干预措施: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) (Device)
Old Able-Bodied individuals
45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
干预措施: Prism adaptation therapy (PAT) + Sham Stimulator (Device)
Stroke with Spatial Neglect (SN) individuals
40-90 years individuals with more than 3 months following right hemisphere stroke.
干预措施: Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) (Device)
Stroke with Spatial Neglect (SN) individuals
40-90 years individuals with more than 3 months following right hemisphere stroke.
干预措施: Prism adaptation therapy (PAT) + Sham Stimulator (Device)
Stroke with Spatial Neglect (SN) individuals
40-90 years individuals with more than 3 months following right hemisphere stroke.
干预措施: Gait Training (Other)
结局指标
主要结局
Change in intracortical excitability [paired pulse transcranial Magnetic Stimulation (TMS)]
时间窗: Pre-training and immediately after training session
Primary Motor Cortex (M1) and TMS from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.
Change in visuospatial pointing behavior
时间窗: Pre-training and immediately after training session
Measured by the neuropsychological laboratory pointing behavior with the Kessler Foundation Neglect Assessment Process (KF-NAP) tool. Patients are asked to point with their eyes closed towards the center (proprioceptive pointing) and eyes open towards a target (visuo-proprioceptive pointing) on a standing calibrated board unaffected hand). The test is scored by measuring the deviation from 0 (midline). Pre-PAT and post-PAT measures are compared, there is no minimum or maximum score. A more negative score (Pre to Post) means improvement in visuospatial alignment (Improved left spatial neglect) in people post-stroke.
Change in corticospinal excitability (single pulse TMS)
时间窗: Pre-training and immediately after training session
Change in corticospinal excitability measured by the change from baseline in motor evoked potentials (MEP) amplitude responses from the hand muscles (first dorsal interossei) and the ankle (soleus) will be measured using Computer software (Biopac) that will record the muscle's responses to TMS pulses (MEPs) through electromyography (EMG) sensors attached to the skin of the legs and/or arms.
次要结局
- Change in the Catherine Bergego Scale (CBS)(Pre-training and immediately after training session)
- Change in weight-bearing asymmetry(Pre-training and immediately after training session)
- Change in computerized line bisection task(Pre-training and immediately after training session)
- Change in spatial neglect deficits(Pre-training and immediately after training session)
研究者
Trisha Kesar
Associate Professor
Emory University