Improving Measurement and Treatment of Post-stroke Neglect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in excitability of fronto-parietal connectivity
研究概览
简要总结
This study examines how to best assess and treat post-stroke neglect. This study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. This study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.
详细描述
It is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). Stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. These individuals also have an imbalance in excitation in the brain. This study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tDCS) combined with arm rehabilitation training (repetitive task-specific practice, RTP) for individuals with neglect following stroke. The investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. This study will also examine assessment of neglect. There are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. Clinicians rely on clinical assessments to inform treatment and document patient progress. Therefore, it is important that investigators more closely examine these existing assessments.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will receive both conditions (active and sham transcranial direct current stimulation paired with arm rehabilitation training [repetitive task-specific practice]) in this cross-over design study. Individuals will be randomized to determine which condition they receive first and the participant and treatment therapist and assessor will be blinded to the order that the interventions are delivered. The PI will oversee randomization so that each patient is randomized and assigned a unique five digit code. When this code is entered on the tDCS device, the device will automatically assign the patient to receive either real or sham stimulation. Because the sham stimulation provides a ramp up/ramp down stimulation for 15 seconds at the start and end of the session the participant may perceive the sham stimulation as active stimulation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic or hemorrhagic stroke 3 months post stroke
- •Fugl-Meyer Upper Extremity (FMA-Upper Extremity) score between 20-56/60
- •Inducible motor evoked potential (MEP) of the abductor pollicis brevis (APB) on the paretic stimulation (TMS)
- •Demonstrate the presence of unilateral neglect (Virtual Reality Lateralized Attention Test score <18)
排除标准
- •History of cortical hemorrhagic stroke
- •Presence of any MRI, TMS, tDCS risk factors including:
- •history of seizures
- •history of brain tumor
- •hardware in skull or spine (e.g. coils, clips)
- •implantable medical device (e.g. pacemaker)
- •metal in body (not compatible with MRI)
- •pregnancy
- •Severe spasticity (Modified Ashworth Scale score 3)
- •Severe aphasia or cognitive impairment limiting participants' comprehension (National Institutes of Health Stroke Scale Level of Consciousness Commands Item score 1 or Best Language Item score 2)
- •Unable to travel to UE Motor Function Laboratory at the Center for Rehabilitation Research in Neurological Conditions (a collaborative, Memorandum of Understanding (MOU) approved, research center Ralph H. Johnson VA Medical Center and the Medical University of South Carolina) for the study
研究组 & 干预措施
Sham transcranial direct current stimulation (tDCS) plus repetitive task-specific practice (RTP)
Single session of bilateral sham parietal cortex tDCS (for 30 minutes) paired with repetitive task-specific practice (RTP)
干预措施: Sham transcranial direct current stimulation (tDCS) (Device)
Active tDCS plus RTP
Single session of bilateral active parietal cortex tDCS (2.0 mA for 30 minutes) paired with repetitive task-specific practice (RTP)
干预措施: Active direct current stimulation (tDCS) (Device)
结局指标
主要结局
Change in excitability of fronto-parietal connectivity
时间窗: Participants will be assessed at baseline and 30 minutes later
Excitability of fronto-parietal connectivity measured by paired pulse twin coil transcranial magnetic stimulation (TMS) test. In each session, the difference in excitability of fronto-parietal connectivity between pre and post stimulation will be measured.
次要结局
- Change in upper extremity kinematics(Participants will be assessed at baseline and 30 minutes later)
- Change on Behavioral Inattention Test(Participants will be assessed at baseline and 1.5 hours later (immediately following experimental condition))