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临床试验/NCT04041063
NCT04041063进行中(未招募)2 期

Rehabilitation and Cortical Remodeling After Surgical Intervention for Spinal Cord Injury

Burke Medical Research Institute2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年7月26日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
6
试验地点
2
主要终点
Change in Box and Blocks test score

研究概览

简要总结

The aim of this study is to determine the effects of rehabilitation on dexterous hand movements and cortical motor map changes in tetraplegic patients following nerve transfer surgery. The working hypothesis is that robot-assisted, intensive rehabilitation will support the return of hand and arm function and strengthen the cortical representations of targeted muscles. The investigators will assess this through TMS mapping and clinical measures of hand and arm function.

详细描述

The recovery of hand and arm function is of critical importance for decreasing long-term care costs and increasing quality of life for individuals with tetraplegia due to spinal cord injury (SCI). A subset of these individuals, with injuries in the mid to low cervical spinal cord, are candidates for nerve transfer surgery. Nerve transfer surgery restores function after SCI through coaptation of redundant, intact donor nerves to recipient nerves arising at or below the level of SCI. The use of nerve transfer after SCI is relatively novel and many patients exhibit a remarkable recovery of hand and arm motor function in the months that follow, however others show a much more limited recovery. The extent of recovery is likely limited, in part, by variability in rehabilitation and the ability of the motor cortex to incorporate the new peripheral circuitry resulting from this surgical procedure. There is a critical need to determine the response of cortical motor networks to nerve transfer and the role that rehabilitation plays in supporting cortical plasticity and motor recovery. If this need is not met, incomplete recovery from this state-of-the-art surgical intervention will persist and the potential application to a wider patient population will not be realized.

The investigators will test the central hypothesis that nerve transfer surgery after cervical SCI creates a novel cortical motor network, which can support the return of dexterous hand/forelimb function through rehabilitation-dependent remodeling. The hypothesis has been based upon 1) previous work in an animal model showing that rehabilitation reshapes cortical motor maps, 2) the pioneering work of a handful of clinicians, including the study collaborator, Justin Brown, that have applied nerve transfer to bypass spinal levels affected by injury, and 3) recent work using transcranial magnetic stimulation (TMS) in human SCI to map the cortical representation of arm muscles in the zone of partial preservation, and the ability to improve hand-arm function through intensive robotic training in chronically impaired subjects. The use of TMS to map cortical motor networks will allow the investigators to measure the cortical reorganization resulting from nerve transfer and determine the extent to which rehabilitation can engage this alternative cortical motor network. The rationale for the proposed studies is that a determination of the mechanisms that support rehabilitation-mediated recovery after nerve transfer will be required for optimizing and refining current clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will not have knowledge of the time point at which they are assessing the participant.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand
  • Motor incomplete or complete lesion (measured by the ASIA Impairment Scale, A, B, C, D).
  • Chronic lesion (at least 6months after the injury)
  • Demonstrate stability of motor examination for at least six months.
  • Retain intact innervation within paralyzed target muscles (axon recipient) as determined by electrodiagnostics.
  • Have muscles innervated by the nerves to be used for the transfers (axon donors) of MRC grade 4/5 or greater and sufficient innervation as determined by electrodiagnostics.
  • Have access to an at home caregiver who can assist with customary postsurgical physical therapy.
  • Ability to give informed consent and understand the tasks involved.

排除标准

  • Presence of potential risk factor for brain stimulation: history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull.
  • History of head trauma and/or cognitive deficit
  • Medically unstable
  • Contraindicated for nerve transfer surgery.

结局指标

主要结局

Change in Box and Blocks test score

时间窗: 1 year post surgery, immediately post training, minus baseline before surgery

The Box and Blocks test measures how many blocks a person can grasp and transfer in one minute. A higher score is associated with better hand function.

次要结局

  • Spinal Cord Independence Measure (SCIM III)(1 year post surgery, immediately post training, minus baseline before surgery)
  • Single pulse transcranial magnetic stimulation(1 year post surgery, immediately post training, minus baseline before surgery)
  • Upper extremity motor score (UEMS)(1 year post surgery, immediately post training, minus baseline before surgery)
  • Modified Ashworth Scale(1 year post surgery, immediately post training, minus baseline before surgery)

研究者

发起方
Burke Medical Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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