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临床试验/NCT03833518
NCT03833518终止不适用

Cortical Biomarkers of Hand Function and Recovery After Injury

VA Pittsburgh Healthcare System1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Number of participants that show significant finger-specific activation prior to the intervention

研究概览

简要总结

This is a pilot study to collect data to support a VA grant submission to study fMRI and neurophysiological predictors of hand function and recovery during a robotic intervention in people with hand impairments due to stroke or spinal cord injury.

详细描述

The loss of arm and hand function after cervical spinal cord injury (SCI) limits independence and increases the cost of care. As a result, Veterans with tetraplegia prioritize restoration of hand and arm function over all other rehabilitation goals. Similar to SCI, stroke of supraspinal areas involved in motor control results in acute movement deficits in more than 85% of survivors. Despite advances in treatment and rehabilitation, 50% of stroke survivors have persistent hand impairment. The loss of hand function and dexterity limits the ability to perform many activities of daily living, and thus limits independence. Since motor deficits are often permanent after SCI and stroke, new strategies are needed to restore dexterous hand function.

Advances in functional imaging have enabled the measurement of finger-related activation patterns in somatosensory cortex, but little is known about how these representational patterns are impacted when hand function is lost. Prior studies of gross movements have reported reorganization of cortical activity after injury. The investigators aim to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

The aim is to improve dexterous hand function by increasing our understanding of finger-related cortical reorganization after lesions to the spinal or supraspinal structures. This understanding could allow discrimination between adaptive and maladaptive patterns underlying hand function and guide restorative therapies. Additionally, imaging biomarkers of injury often track with functional recovery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Normal or corrected to normal vision
  • •Hand impairment due to spinal cord injury or stroke
  • •Weakness of fingers
  • •One year after stroke or spinal cord injury
  • •Some proprioception (can feel when finger is moved, without seeing)
  • •Minimal spasticity

排除标准

  • •Implanted metal with is unsafe for MRI
  • •Pregnant or expecting to become pregnant
  • •History of hand surgery which is under evaluation
  • •Cognitive or language issues that would interfere with following directions
  • •Other neurological disorder that would affect movement
  • •History of seizure or epilepsy
  • •Body weight > 300 pounds

研究组 & 干预措施

Hand impairment due to stroke or spinal cord injury

Experimental

Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

干预措施: Rehabilitation using motorized glove for stroke and spinal cord injury (Other)

Hand impairment due to stroke or spinal cord injury

Experimental

Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

干预措施: Functional MRI for stroke and spinal cord injury (Other)

Hand impairment due to stroke or spinal cord injury

Experimental

Individuals who have experienced a sub-cortical stroke or a cervical spinal cord injury resulting in loss of hand function.

干预措施: Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury (Other)

结局指标

主要结局

Number of participants that show significant finger-specific activation prior to the intervention

时间窗: Baseline, prior to intervention, week 1

The investigators will use functional magnetic resonance imaging (fMRI) to measure cortical activity relating to finger-specific brain activation before the rehabilitation intervention.

次要结局

  • Change from baseline finger strength after rehabilitation intervention(After intervention, 12 weeks)
  • Change from baseline in finger dexterity after rehabilitation intervention(After intervention, 12 weeks)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Jennifer Collinger

Research Biomedical Engineer

VA Pittsburgh Healthcare System

研究点 (1)

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